Home › OTTO BOCK HEALTHCARE › Empower
Empower
OTTO BOCK HEALTHCARE · Model 1A1-1=R27-6/7-15 · UDI-DI 04064409013197
1
510(k) clearances
85
Adverse events
10
Recalls
10
Facilities
Description
1A1-1 Empower, R, black, brown
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-25 | Ossur H / F | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| 2024-03-25 | Ossur H / F | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| 2024-03-25 | Ossur H / F | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| 2024-03-25 | Ossur H / F | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls. |
| 2023-12-26 | Ossur H / F | Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power t |
| 2022-08-29 | Ossur Americas | Battery may dislodge from the Power Knee |
| 2015-08-12 | Otto Bock Healthcare Product | Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions |
| 2015-02-26 | Ossur H / F | The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully |
| 2014-06-02 | Ability Dynamics LLC | Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure. |
| 2012-10-26 | iwalk inc | Battery may over-heat during charging and smoke |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.