CLASS II Device recall · Reported 31 Jul 2013 · FDA Enforcement Report
TotalCare Bed used with AccuMax Quantum VPC mattress recalled
Hill-Rom is recalling TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, distributed nationwide in the US. The recall was initiated on 30 May 2013 and the FDA has classified it as Class II.
Check your package
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-1794-2013
- FDA event ID
- 65259
- Recalling firm
- Hill-Rom, Batesville, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 May 2013
- FDA classified
- 23 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 30 May 2013 | Recall initiated by company | |
| 23 Jul 2013 | Classified by FDA | +54 days |
| 31 Jul 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to get back into the bed may miss the seat and sit on the foot section instead. The patient can slide down to the floor, or fall, with possible injury.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Where it was distributed
Worldwide distribution: USA (nationwide) and countries of: Canada, Colombia, Nigeria, Kuwait and Saudi Arabia.
Questions about this recall
Why was it recalled?
When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to get back into the bed may miss the seat and sit on the foot section instead. The patient can slide down to the floor, or fall, with possible injury.
Which lots are affected?
Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384. The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013
Where was it sold?
Worldwide distribution: USA (nationwide) and countries of: Canada, Colombia, Nigeria, Kuwait and Saudi Arabia.
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 26 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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Other Surgical Instruments recalls
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| Device | CLASS II | Scout MD recalled by Merit Medical Systems | Merit Medical Systems | Other | 7 states |
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