The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that i
FDA device recall Z-2283-2013 · posted 2013-09-26 · Terminated
Recall details
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Reason for recall
- The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.
- Action taken
- Stryker sent an Urgent Medical Device Recall Notification letter dated August 19, 2013, to all affected consignees. The notification described the affected product, reason for recall, potential hazards, and recall customer actions and reply instructions. A Stryker Representative will contact the consignees to arrange a time to repair the unit(s) and eliminate the risk of the potential interference . Urgent questions or concerns are directed to Blaine Burnett (269)389-6954. Stryker Medical business hours are Monday-Friday 8 a.m-5 p.m. (ET). For questions regarding this recall call 269-324-6609.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FNL
- Quantity affected
- 61 units
- Distribution
- Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
- Date initiated
- 2013-08-19
- Date posted
- 2013-09-26
- Date terminated
- 2014-01-29
- Location
- Portage, MI
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