Z-0274-2016Class II
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Hill-Rom Inc. / initiated 2015-10-07 / Terminated / root cause: design
Hill-Rom, Inc. began a recall of Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed on . FDA classified it as Class II and gives the reason as "Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0274-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Hill-Rom Inc.
- Product
- Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
- Product code
- FNL Bed, Ac-Powered Adjustable Hospital
- Reason for recall
- Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Hill-Rom initiated Phase 1 of the recall on October 2, 2015, which included notices of the recall being issued to customers via certified mail, which included safety information on how to properly use the bed, and instructions to forward the information on if devices have been transferred. Phase 2 for the recall will include the distribution of caps for the edges of the bed to be placed on by the customers. Customers may contact Hill-Rom Technical Support at 800-445-3720.
- Quantity in commerce
- 12251 units
- Distribution
- Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ. CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV., and to the countries of : Canada and France.
- Product codes and lots
- Product # P3930A; Dates of Manufacture 5-DEC-2007 to 14-SEP-2015; Serial numbers from I325AR0038 thru Q257AR2299
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0274-2016 | Class II | Terminated | Voluntary: Firm initiated |
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