ClearanceBrief
Recall Z-1036-2015 ยท FNL Bed, Ac-Powered Adjustable Hospital

Invacare Corporation

G- Series Beds; G29 full length bed rails assembly

DateFeb 2, 2015 (initiated Dec 5, 2014)
StatusTerminated
ReasonInvacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.
Root causeNonconforming Material/Component
ActionInvacare sent an Urgent Medical Device Recall letter dated December 5, 2014, to all affected customers. The letter identified the product and the problem. Customers with questions should call 440-329-7996. For questions regarding this recall call 440-329-6875.
Quantity2499 units
DistributionUS Nationwide Distribution including OH, CO, MO, and NY.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.