ClearanceBrief
Recall Z-1912-2011 ยท FNG Lift, Patient, Ac-Powered

Penner Mfg Inc

Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models 382000-1 (right entry) and 382000-1L (left entry). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.

DateApr 8, 2011 (initiated Jan 19, 2009)
StatusTerminated
ReasonIncomplete weld on the pillar mounting bracket
Root causeEmployee error
ActionThe firm, Penner, sent an undated letter flagged "Important Safety Inspection: Action Required" via certified mail on January 19, 2009 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect the Penner Patient Transfer for any missing Welds of the Pillar Mounting Bracket; inspect the areas indicated in the enclosed photos to confirm the bracket is welded on all edges to the main frame of the base; complete the inspection, and complete and return the attached WELD INSPECTION RESULTS OF PENNER PATIENT TRANSFER form via fax t
QuantityModel 382000-1 - 117 lifts; Model 382000-1L - 29 lifts
DistributionWorldwide distribution: USA and countries including: Canada and Mexico.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.