| 2025-06-10 |
Class II
|
Ongoing |
Z-0287-2026 |
SM_40HF_BDC3, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0286-2026 |
SM_40HF_BDC, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0285-2026 |
SM_40HF_B_D_VIR3.004, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0284-2026 |
SM_40HF_B_D_VIR3, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0283-2026 |
SHIMADZU RF.004, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0282-2026 |
SED URS LP, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0281-2026 |
RADPRO MOBILE, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0280-2026 |
Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0279-2026 |
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0278-2026 |
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0277-2026 |
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0276-2026 |
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0275-2026 |
Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0274-2026 |
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0273-2026 |
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0272-2026 |
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0271-2026 |
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0270-2026 |
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0269-2026 |
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0268-2026 |
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0267-2026 |
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0266-2026 |
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0265-2026 |
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0264-2026 |
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0263-2026 |
Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0262-2026 |
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0261-2026 |
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0260-2026 |
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0259-2026 |
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0258-2026 |
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0257-2026 |
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0256-2026 |
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0255-2026 |
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0254-2026 |
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0253-2026 |
Model Number 40KWMOBILE3.899, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0252-2026 |
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0251-2026 |
Model Number 40KWFXPLUS-710CW, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0250-2026 |
Model Number 40KWFXPLUS.889, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0249-2026 |
Model Number 40KWFXPLUS.005, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0248-2026 |
Model Number 40KWFXPLUS.004, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0247-2026 |
Model Number 40KWFXPLUS.002, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0246-2026 |
Model Number 40KWFXPLUS, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0245-2026 |
Model Number 40KW-FX.899, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0244-2026 |
Model Number 40KWFX, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0243-2026 |
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-0242-2026 |
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) |
— |
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions… |
| 2024-01-22 |
Class II
|
Ongoing |
Z-1754-2024 |
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF… |
— |
Potential interference with the anti-fall system. |
| 2023-12-13 |
Class II
|
Ongoing |
Z-0781-2024 |
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm.… |
— |
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. |
| 2023-05-23 |
Class II
|
Ongoing |
Z-2045-2023 |
wDR 2.2 Mobile Digital Diagnostic X-Ray System |
— |
There is a software login in issue that may prevent the user from logging in. |
| 2023-02-06 |
Class II
|
Ongoing |
Z-1203-2023 |
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system |
— |
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. |
| 2023-02-06 |
Class II
|
Ongoing |
Z-1202-2023 |
Phoenix mKDR, digital mobile diagnostic x-ray system |
— |
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. |
| 2022-08-12 |
Class II
|
Ongoing |
Z-0182-2023 |
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500 |
— |
Due to un-commanded movement of mobile x-ray unit. |
| 2021-10-14 |
Class II
|
Ongoing |
Z-1083-2024 |
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 |
— |
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the sys… |