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Fresenius Medical Care
FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD · Model T688B · UDI-DI 04052882003163
10
510(k) clearances
554
Adverse events (24 deaths)
5
Recalls
54
Facilities
Description
Electric Treatment chair for use in dialysis, day surgery and oncology applications. The chair is intended for patients with weight not exceeding 660 lbs (300kg)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-04 | Altimate Medical, Inc. | Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket t |
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden |
| 2020-07-06 | Golden Technologies, Inc. | Suspect poor weld on back KD bar. |
| 2013-06-18 | Invacare Corporation | There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual). |
| 2004-06-07 | Pride Mobility Products Corp | The heating pad on these Lift Chairs may tear at the entry point causing a short and/or overheating, which can damage the chair. |
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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.