Hill-Rom brand Affinity three birthing bed
FDA Recall Z-0902-03 · Posted 2003-05-29
Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeKNC
Date Initiated2003-04-24
Date Terminated2003-09-25
Reason for Recall
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
Firm Action
Letters dated April 24, 2003 were sent to each consignee instructing them to inspect the beds for power cords with non-flared ground pins, to cut plug off any such cords when found, and replace these plugs with new plugs with the flared ground pin. [The type of plug on the unit can be seen by the naked eye, as the plug is transparent plastic molding.]
Root Cause
Other
Distribution Pattern
United States, Bahamas, Bermuda, Canada, Colombia, Costa Rica, Dominican Republic, Guam, Japan, Mexico, Panama, Saudi Arabia, South Korea, Taiwan and Venezuela
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.