Recall Z-2082-2012— Hill-Rom, Inc.
Class II · Terminated
Class II FDA medical device recall by Hill-Rom, Inc., initiated 2012-04-02, terminated 2015-07-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.. Reason: During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural.
- Recalling firm
- Hill-Rom, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-02
- Terminated
- 2015-07-21
- Firm location
- Batesville, IN, United States
Product description
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.
Reason for recall
During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural
Data sourced from openFDA. This site is unofficial and independent of the FDA.