| 2022-01-14 |
Class II
|
Terminated |
Z-0783-2022 |
(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX co… |
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Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to s… |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0640-2022 |
Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015 |
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Missing bushing on Liko M220 and M230 causing wear and potential for patient falling |
| 2021-12-23 |
Class II
|
Ongoing |
Z-0639-2022 |
Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010 |
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Missing bushing on Liko M220 and M230 causing wear and potential for patient falling |
| 2021-10-14 |
Class II
|
Terminated |
Z-0402-2022 |
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call… |
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An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced. |
| 2021-08-11 |
Class II
|
Ongoing |
Z-2601-2021 |
LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2… |
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Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is l… |
| 2021-08-11 |
Class II
|
Ongoing |
Z-2600-2021 |
LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the c… |
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Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is l… |
| 2021-08-11 |
Class II
|
Ongoing |
Z-2599-2021 |
Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the c… |
— |
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is l… |
| 2021-08-11 |
Class II
|
Ongoing |
Z-2598-2021 |
FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the cente… |
— |
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is l… |
| 2021-08-11 |
Class II
|
Ongoing |
Z-2597-2021 |
OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center… |
— |
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is l… |
| 2021-05-28 |
Class II
|
Terminated |
Z-2156-2021 |
Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) o… |
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Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperl… |
| 2020-12-18 |
Class I
|
Terminated |
Z-0925-2021 |
Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensiv… |
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Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail syst… |
| 2020-06-30 |
Class II
|
Terminated |
Z-2738-2020 |
Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other comp… |
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Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user i… |
| 2020-06-30 |
Class II
|
Terminated |
Z-2737-2020 |
Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complicatio… |
— |
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user i… |
| 2020-04-30 |
Class II
|
Terminated |
Z-2246-2020 |
Centrella Smart+ Bed, Catalog Number P7900 |
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The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call … |
| 2020-02-14 |
Class II
|
Terminated |
Z-1554-2020 |
NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is c… |
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There is a software issue which may result in failure to monitor or control patient's bed exit mechanism. |