Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, stan
FDA device recall Z-2750-2016 · posted 2016-09-08 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Action taken
- Hill-Rom Inc. initiated a voluntary recall of the Affinity Four Birthing Beds on July 15, 2016, with letters to customers mailed certified via FedEx. Customers were asked to do the following: During use, if you encounter a situation where the CPR mechanism fails to activate, the head of the bed can still be lowered, electrically, using the siderail articulation controls. A Hill-Rom representative will be contacting each facility to make arrangements for replacing the affected head drive. Please pass this notice on to all those who need to be aware within your organization and/or to any organization where the affected devices have been transferred. If you have any questions concerning this correction, please contact Hill-Rom Technical Support at 800-445-3720.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KNC
- Quantity affected
- 94 beds
- Distribution
- US Distribution to the states of : CA, FL, IN, KS, LA, MI, MO, NC, NY, OK, OR, PA, TN, TX, WA, WY Foreign:BULGARIA, INDIA, UNITED ARAB EMIRATES
- Date initiated
- 2016-07-15
- Date posted
- 2016-09-08
- Date terminated
- 2017-03-23
- Location
- Batesville, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFFINITY BED MODEL 3600 SERIES (K915779) | Hill-Rom, Inc. | 1993-02-24 |