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Recall Observatory FDA recall evidence

Device product

ProCuity bed series, model number 3009, item number: 300900000000,

Z-0424-2024

August 30, 2023

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 93317
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0424-2024

Official wording

Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Code information: UDI-DI (GTIN): 07613327512656. Serial numbers: 2207000698, 2207000676, 2207000619, 2206001100, 2206001090, 2206001089, 2206001086, 2206001084, 2208001745, 2208001734, 2208001725, 2208001724, 2208000397, 2208000394, 2208000032, 2209002157, 2209002158, 2209002165, 2210000711 , 2210000721 , 2210000723 , 2111000494 , 2206001248 , 2206001250 , 2206001265 , 2206001273 , 2206001317 , 2207000023 , 2207000078 , 2207000303 , 2207000307 , 2207000342 , 2207000350 , 2207000353 , 2207000358 , 2110002355 , 2108002264 , 2209000269 , 2106002756 , 2103001270 , 2109000898 , 2109001004 , 2108001784 , 2107001856 , 2208000874 , 2208000873 , 2208000814 , 2208000805 , 2104001582 , 2104003135 , 2104003758 , 2104003772 , 2104003778 , 2104003786 , 2104003798 , 2104004415 , 2104004431 , 2104004441 , 2104004491 , 2104004537 , 2104004993 , 2104004997 , 2104004998 , 2104005012 , 2104005013 , 2105000649 , 2105000657 , 2105001594 , 2105001621 , 2107000100 , 2107000102 , 2208000795 , 2108000833 , 2211004443, 2211004441, 2211004293, 2211004095 , 2211004050 , 2211003541 , 2209002035 , 2205000370 , 2208001249 , 2208001250 , 2202001692 , 2108002072 , 2108002161 , 2202001958 , 2202002003 , 2205000361 , 2109001797 , 2208001175 , 2208001162 , 2208001044 , 2107001827 , 2208000995 , 2208000992 , 2208000980 , 2208000910 , 2208000854 , 2201001114 , 2208001148 , 2208001129 , 2207001981 , 2106001072 , 2206001367 , 2209002143 , 2208000569 , 2208000568 , 2208000507 , 2208000473 , 2109002479 , 2210002762 , 2112002175 , 2112001663 , 2112000049 , 2106002744 , 2109003074 , 2110000077 , 2110000082 , 2105000094 , 2105004609 , 2108000595 , 2104000805 , 2108001834 , 2108001836 , 2208000577 , 2208000496 , 2201000319 , 2203002461 , 2108002656 , 2203001282 , 2109001070 , 2209002133 , 2112002188 , 2112001020 , 2211000729 , 2109002517 , 2103003835 , 2104000245 , 2207001763 , 2107000933 , 2102000258 , 2110000967 , 2110000965 , 2103000446 , 2108002753 , 2108002726 , 2108002685 , 2108002683 , 2108002673 , 2108002556 , 2108002533 , 2108002507 , 2105002810 , 2112000853 , 2105002764 , 2107000759 , 2209000686 , 2108001946 , 2108001932 , 2112001628 , 2111000528 , 2110001582 , 2111000399 , 2111000286 , 2111000092 , 2111001950 , 2110002881 , 2110002369 , 2207000860 , 2207000862 , 2109002846 , 2110002291 , 2110001555 , 2110001362 , 2108002306 , 2201000283 , 2108001939 , 2107001826 , 2210000028 , 2210000004 , 2111000392 , 2110002880 , 2110002867 , 2110000448 , 2110000458 , 2110002828 , 2110002819 , 2110002405 , 2110002399 , 2110001809 , 2101002085 , 2109002376 , 2110001384 , 2110002668 , 2111000409 , 2111000533 , 2112000343 , 2112000347 , 2109002824 , 2209002123 , 2208000334 , 2208000331 , 2107000836 , 2212000241 , 2212000236, 2212000223, 2212000217 , 2212000215 , 2208000075 , 2201000857 , 2108001491 , 2108001490 , 2108000825 , 2009000613 , 2106001220 , 2106001200 , 2106001197 , 2104001603 , 2201000196 , 2208001930 , 2208001924 , 2208001886 , 2210002945 , 2208001860 , 2111000090 , 2107001825 , 2109002592 , 2107000127 , 2107000115 , 2105002209 , 2205000426 , 2107001697 , 2202001129 , 2105002197 , 2105002192

Distribution pattern: Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Field note

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