Primus Medical Recalls AC Powered Adjustable Bed Frames
Primus Medical LLC is recalling 1,726 AC powered adjustable bed frames used in nursing facilities because the head deck actuator bracket may separate from the frame.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device that poses a risk of harm (injury) to users, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Primus Medical LLC is recalling 1,726 AC powered adjustable bed frames. These products are used in nursing facilities and were distributed nationwide in the United States and in Canada. The recall involves units with code PCB900 manufactured between September 13, 2010, and May 22, 2012.
The recall was initiated after the firm received several complaints that the head deck actuator bracket had separated from the bed frame. This defect poses a risk of injury to patients or staff if the bed components shift or fail while in use.
Consumers and facility managers should stop using the affected bed frames immediately. They should contact Primus Medical LLC for instructions on how to resolve the issue, which may involve repair or replacement.
The recalled product
- Product
- AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.
- Manufacturer
- Primus Medical LLC
- Category
- Medical Device — Hospital Bed
- Affected units
- 1,726
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- PCB900 manufactured between 09/13/2010 and 05/22/2012
Distribution
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