Hill-Rom Recalls Affinity Four Birthing Beds Due to Fall Risk
Hill-Rom is recalling 12,726 Affinity Four Birthing Beds because bed movement during labor may cause patient or caregiver falls.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient or caregiver falls, which constitutes a significant injury risk.
Plain-English summary
Hill-Rom, Inc. is recalling 12,726 Affinity Four Birthing Beds (P3700) distributed worldwide. The recall involves devices with serial numbers ranging from H331AA4785 to N081AA7966. These beds are intended for use in acute care Labor and Delivery settings.
The recall was initiated because a previous field corrective action failed to eliminate the hazard of patient falls. Bed movement immediately prior to or during the birthing process may create distractions and delays, which can result in patient or caregiver falls or contribute to deviations in medical procedures such as IV insertion or epidural administration.
Hospitals and healthcare facilities should contact Hill-Rom for instructions on how to address the defect. The source text does not specify a deadline or specific remediation steps beyond the initial notification.
The recalled product
- 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…
- Manufacturer
- Hill-Rom, Inc.
- Category
- Medical Device — Hospital Bed
- Hazard
- Affected units
- 12,726
Distribution
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