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U.S. Department of Health and Human Services

Class 2 Device Recall A625 lift

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  Class 2 Device Recall A625 lift see related information
Date Initiated by Firm January 30, 2017
Date Posted February 28, 2017
Recall Status1 Terminated 3 on December 04, 2017
Recall Number Z-1406-2017
Recall Event ID 76351
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product A-series lift - A625 Manual Part No. 324117. Prism Medical.
Code Information A6MC000016 A6MC000019 A6MC000020 A6MC000021 A6MC000022 A6MC000023 A6MC000024 A6MC000025 A6MC000026 A6MC000027 A6MC000028 A6MC000029 A6MC000030 A6MC000031 A6MC000009 A6MC000002 A6MC000004 A6MC000001 A6MC000003 A6MC000005 A6MC000006 A6MC000007 A6MC000008 A6MC000010 A6MC000011 A6MC000012 A6MC000013 A6MC000014 A6MC000015 A6MC000017 A6MC000018 A6MC000096 A6MC000087 A6MC000088 A6MC000090 A6MC000091 A6MC000092 A6MC000093 A6MC000094 A6MC000048 A6MC000068 A6MC000070 A6MC000072 A6MC000073 A6MC000074 A6MC000075 A6MC000078 A6MC000079 A6MC000081 A6MC000082 A6MC000083 A6MC000085 A6MC000086 A6MC000042 A6MC000043 A6MC000045 A6MC000046 A6MC000047 A6MC000049 A6MC000050 A6MC000051 A6MC000052 A6MC000053 A6MC000054 A6MC000055 A6MC000056 A6MC000057 A6MC000058 A6MC000059 A6MC000060 A6MC000061 A6MC000062 A6MC000063 A6MC000064 A6MC000066 A6MC000071 
Recalling Firm/
Manufacturer		 ErgoSafe Products, LLC (DBA) Prism Medical
10888 Metro Ct
Maryland Heights MO 63043-2413
For Additional Information Contact Steve P. Kilburn
314-219-8614
Manufacturer Reason
for Recall		 During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.
FDA Determined
Cause 2		 Device Design
Action The recalling firm called each customer on Jan 30, 2017 to review the recall and schedule a time for the firm to come to their facility to personally swap the recalled product for a new device. The FSNs were sent on Jan 31, 2017.
Quantity in Commerce 76
Distribution Product was distributed to MT and NV; one VA consignee.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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