Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support ideally suite
FDA device recall Z-1317-2009 · posted 2009-05-01 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- An e-ring may not have been installed during production, which could result in an inability to latch the siderail.
- Action taken
- Consignees were notified by an Urgent Medical Device Correction letter dated 3/9/09 and were instructed that a Hill-Rom technician will visit each consignee to inspect and to correct the beds, if necessary. The firm asks that consignees locate and test their beds to make sure the siderails are latching correctly; forward a copy of the letter to users that were loaned or purchased the device and notify Hill-Rom of their new locations or owners; and if affected beds were disposed of or are no longer in use, to inform the firm of their serial numbers. If there are questions customers should contact their Hill-Rom Technical Support for their geographic region.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FNL
- Quantity affected
- 53 beds
- Distribution
- Worldwide Distribution -- USA and Canada.
- Date initiated
- 2009-03-09
- Date posted
- 2009-05-01
- Date terminated
- 2010-10-13
- Location
- Batesville, IN
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