Recall Z-0338-2010
Hill-Rom, Inc. · initiated April 20, 2009
Product
Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.
Codes / lots: All units shipped prior to 3/6/09. Serial numbers I331AR0046, I331AR0061, I331AR0062, I331AR0063, I333AR0088, I333AR0089, I333AR0090, I333AR0091, I333AR0092, I333AR0093, I333AR0094, I333AR0095, I334AR0096, I334AR0097, I334AR0098, I334AR0099, I334AR0100, I334AR0101, I334AR0102, I334AR0105, I334AR0106, I334AR0107, I334AR0108, I334AR0109, I334AR0110, I338AR0111, I338AR0112, I338AR0114, I338AR0115, I338AR0116, I338AR0118, I338AR0120, I338AR0121, I338AR0124, I338AR0125, I338AR0126, I339AR0148, I339AR0149, I339AR0150, I340AR0153, I340AR0155, I340AR0156, I340AR0157, I340AR0158, I340AR0159, I340AR0160, I340AR0161, I340AR0162, I340AR0163, I340AR0165, I340AR0166, I340AR0167, I340AR0168, I340AR0171, I348AR0177, I349AR0177, I349AR0179, I349AR0180, I349AR0181, I349AR0182, I349AR0183, I349AR0184, I349AR0185, I349AR0186, I349AR0187, I349AR0188, I349AR0189, I349AR0190, I349AR0191, I349AR0192, I349AR0193, I351AR0199, I351AR0200, I351AR0201, I351AR0202, I351AR0203, I351AR0204, I351AR0205, I351AR0206, I351AR0207, I351AR0208, I351AR0209, I351AR0210, I351AR0211, I351AR0212, I351AR0213, I351AR0214, I351AR0215, I351AR0216, I351AR0217, I351AR0218, I352AR0219, I352AR0220, I352AR0221, I352AR0222…
Reason for recall
The siderails may exhibit false latching, or unintentional lowering, or may become inoperable.
FDA-determined cause: Process control
Action taken
Hill Rom notified consignees by recall letter dated 4/20/09 and advised them of the problem and requested them to locate the beds. Consignees with patients in need of siderails were directed to be moved to a different model bed with siderails and, if the patient did not need siderails; consignees were requested to remove the siderails, move the siderails to a stowed position, to tie the siderail to the bed frame or to tag the siderail as out of service. The letter stated the consignee would be contacted within 90 days by a firm representative to do a correction on all affected units.
Details
- Recall number
- Z-0338-2010
- Initiated
- April 20, 2009
- Posted by FDA
- November 18, 2009
- Terminated
- October 15, 2010
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 4017 beds
- Distribution
- Worldwide distribution: USA, Canada, France, India, Singapore and Spain.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN