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AFCS PEARLS™ Backrest
Synergie Nederland B.V. · Model SAT2 · UDI-DI 08720387388141
10
510(k) clearances
1,460
Adverse events (33 deaths)
9
Recalls
6
Facilities
Description
Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air permeable backrest (manually adjustable)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-02-03 | Hill-Rom, Inc. | The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identif |
| 2012-02-03 | Hill-Rom, Inc. | The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identif |
| 2009-06-24 | Hill-Rom Manufacturing, Inc. | Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. |
| 2009-06-24 | Hill-Rom Manufacturing, Inc. | Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. |
| 2004-03-22 | Kinetic Concepts, Inc | Battery outgassing of powered hospital beds |
| 2003-05-05 | Hill-Rom Manufacturing, Inc. | Malfunction of side-rail latching pin coupled with inadequate directions for use. |
| 2003-05-05 | Hill-Rom Manufacturing, Inc. | Malfunction of side-rail latching pin coupled with inadequate directions for use. |
| 2002-01-14 | Hill-Rom Manufacturing, Inc. | Power cord overheating |
| 1997-06-01 | Kinetic Concepts, Inc | Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge. |
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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.