Bed, Flotation Therapy, Powered
Stryker Medical's record for this product code
MDR events105All time
Recalls2All time
510(k) clearances0All time
Recent MDR events
105 adverse event reports on file
- AIR PLUS PUMPJul 27, 2026Malfunction0001831750-2026-99364
- AIR PLUS PUMPApr 23, 2026Malfunction0001831750-2026-99229
- AIR PLUS PUMPApr 28, 2025Malfunction0001831750-2025-00469
- STRYKER CHAIR CUSHIONFeb 13, 2025Malfunction21379283
- CUSHION ASSY SPR-PLUS BOX OF 6Oct 29, 2024Malfunction0001831750-2024-01366
- AIR PLUS PUMPOct 28, 2024Malfunction0001831750-2024-01224
- STRYKER ISOFLEX MATTRESS AND FOAMOct 25, 2024MalfunctionMW5161665
- STRYKER ISOFLEX MATTRESS AND FOAMOct 25, 2024MalfunctionMW5161666
- STRYKER ISOFLEX MATTRESS AND FOAMOct 25, 2024MalfunctionMW5161667
- STRYKER ISOFLEX MATTRESS AND FOAMOct 25, 2024MalfunctionMW5161668
Recalls
2 recall events for this product code
- TerminatedAug 9, 2013
Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi
View FDA record ↗ - TerminatedUnknown
Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Stryker Medical under this product code.