Recall Z-0284-2016— ErgoSafe Products, LLC (DBA) Prism Medical
Class II · Terminated
Class II FDA medical device recall by ErgoSafe Products, LLC (DBA) Prism Medical, initiated 2015-09-08, terminated 2017-05-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.. Reason: Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use.
- Recalling firm
- ErgoSafe Products, LLC (DBA) Prism Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-08
- Terminated
- 2017-05-04
- Firm location
- Maryland Heights, MO, United States
Product description
Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
Reason for recall
Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use
Data sourced from openFDA. This site is unofficial and independent of the FDA.