Recall Z-1946-2013 ยท IOQ Bed, Flotation Therapy, Powered
Stryker Medical Division of Stryker Corporation
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
| Date | Aug 9, 2013 (initiated Jul 12, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | On 7/12/13, an URGENT MEDICAL DEVICE RECALL NOTIFICATION was mailed to consignees. The notification addressed the affected product and issue, potential hazard, actions needed including faxing (269-488-8691) or emailing (ProductFieldAction@stryker.com) the attached reply form to confirm receipt of notification, and risk mitigation. Please contact the firm at 269-389-8129 if you have questions or concerns regarding this recall. Business hours are M-F 8am-5pm(ET). |
| Quantity | 586 units |
| Distribution | Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.