CLASS II Device recall · Reported 1 Aug 2012 · FDA Enforcement Report

Affinity Four Birthing Bed P3700 recalled by Hill-Rom

Hill-Rom is recalling Affinity Four Birthing Bed P3700, distributed nationwide in the US. The recall was initiated on 2 Apr 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966

Quantity recalled12,726 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2082-2012
FDA event ID: 62453
Recalling firm: Hill-Rom, Batesville, IN
Classification: Class II
Status: Terminated
Recall initiated: 2 Apr 2012
FDA classified: 26 Jul 2012
Reported: 1 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Wheelchairs, Beds & Lifts

Timeline

2 Apr 2012	Recall initiated by company
26 Jul 2012	Classified by FDA	+115 days
1 Aug 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide and countries including: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, United States, US Virgin Islands, Venezuela and Vietnam

Nationwide Puerto Rico

Questions about this recall

Is Affinity Four Birthing Bed P3700 recalled?

Yes. Hill-Rom recalled Affinity Four Birthing Bed P3700 on 2 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-2082-2012.

Why was it recalled?

Which lots are affected?

Affinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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