Recall Z-3183-2018— Med-Mizer, Inc.
Class II · Terminated
Class II FDA medical device recall by Med-Mizer, Inc., initiated 2018-07-25, terminated 2019-10-11. FDA's recall record names no specific 510(k) clearance for this event. Product: PR1000 Pivot Rehab Bed AC powered adjustable bed.. Reason: Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. A failure would result in the resident requiring to be transferred to a different bed until repairs can be made.
- Recalling firm
- Med-Mizer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-25
- Terminated
- 2019-10-11
- Firm location
- Batesville, IN, United States
Product description
PR1000 Pivot Rehab Bed AC powered adjustable bed.
Reason for recall
Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. A failure would result in the resident requiring to be transferred to a different bed until repairs can be made
Data sourced from openFDA. This site is unofficial and independent of the FDA.