| 2023-07-25 |
Class II
|
Ongoing |
Z-2592-2023 |
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each packa… |
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During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on… |
| 2023-05-02 |
Class II
|
Ongoing |
Z-1980-2023 |
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). |
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The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "releas… |
| 2022-08-22 |
Class II
|
Completed |
Z-0148-2023 |
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carb… |
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Weak skin adhesion. |
| 2020-12-10 |
Class II
|
Ongoing |
Z-1134-2021 |
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patie… |
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Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. |