Z-0429-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- August 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Reason for Recall
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Distribution Pattern
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Code Information
UDI-DI (GTIN): 07613327541229. Serial numbers: 2203001674, 2203001673, 2203001662, 2203001328, 2112001472, 2201001284, 2201001262, 2201001258, 2210002490 , 2210002246 , 2203001157 , 2210000264 , 2108002021 , 2207000782 , 2207000778 , 2208000442 , 2107000549 , 2103001807 , 2107000349 , 2206000057 , 2206000027 , 2206000007 , 2206000001 , 2105001397 , 2105001386 , 2202000874 , 2202000831 , 2203002026 , 2203001847 , 2105001777 , 2105001733 , 2105001730 , 2105001704 , 2105001694 , 2212001339, 2212001353, 2212001354, 2212001371 , 2209001039 , 2107000414 , 2104003152 , 2106002729 , 2106002525 , 2210002613 , 2210002592 , 2209001197 , 2212001462, 2209000157 , 2209000148 , 2209000132 , 2209000131 , 2209000129 , 2209000124 , 2208002626 , 2208002260 , 2208002189 , 2208002119 , 2208002117 , 2109001048 , 2102003094 , 2101002546 , 2101002504 , 2110000684 , 2203000449 , 2203000444 , 2202000882 , 2212000954 , 2212000966 , 2212000971 , 2212000987 , 2212000995 , 2212001051 , 2212001056 , 2212001072 , 2209001661 , 2212000653, 2212000632 , 2212000137 , 2212000053 , 2110001030 , 2202000968 , 2210002107 , 2210002092 , 2210002090 , 2102002723 , 2102002735 , 2210002089 , 2210002086 , 2210002064 , 2210001780 , 2102002782 , 2102001851 , 2210001325 , 2210001382 , 2210001395 , 2211000549 , 2211003332 , 2211000994 , 2211000932 , 2111001755 , 2111001751 , 2209000399 , 2206000124 , 2206000106 , 2104003071 , 2111000703 , 2111001128 , 2111000790 , 2111000789 , 2012000962 , 2011000951 , 2011000882 , 2109002087 , 2109002064 , 2109002045 , 2011002330 , 2112001153 , 2112001143