Recall Z-0582-2008
Hill-Rom, Inc. · initiated November 21, 2007
Product
Hill-Rom Affinity Two Birthing Bed, Model P3600.
Codes / lots: All units. (**Affinity beds manufactured with serial number I290AA7395 or greater are not impacted by this correction.)
Reason for recall
Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.
FDA-determined cause: Device Design
Action taken
Consignees were notified of the problem via an Urgent Medical Device Correction letter dated 11/21/07. Users were informed that they would be receiving a free upgrade kit for all of their Affinity Birthing Beds. The Kit includes two plugs per bed, an insertion tool, and full written instructions. An instruction video is available at www.Hill-Rom.com.
Details
- Recall number
- Z-0582-2008
- Initiated
- November 21, 2007
- Posted by FDA
- February 22, 2008
- Terminated
- September 22, 2009
- Product code
- KNC – Table, Obstetric (And Accessories)
- Quantity
- 32,379 for all model numbers
- Distribution
- Worldwide Distribution-- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon…
- Recalling firm
- Hill-Rom, Inc., Batesville, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0581-2008 | Hill-Rom Affinity Birthing Bed, Model P3600.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | 11/21/2007Terminated |
| Z-0583-2008 | Hill-Rom Affinity Three Birthing Bed, Model P3700A.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | 11/21/2007Terminated |
| Z-0584-2008 | Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | 11/21/2007Terminated |