Device product
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Z-1083-2024
Product summary
- Firm
- SEDECAL SA
- Event
- Event 93651
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 851 devices
- Official record key
device-enforcement:Z-1083-2024
Official wording
Reason: While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
Code information: Model 712001 - UDI-DI 00884838028586, all serial numbers; Model 712002 - UDI-DI 00884838082373, all serial numbers; Model 712004 - UDI-DI 08436046002173, all serial numbers; Model 712006 - UDI-DI 00884838091504, serial numbers: SN20410556 and SN21410184; Model 712007 - UDI-DI)08436046002357, serial numbers: 26, 27, 19410038, 19410044, 19410046, 21410261, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410339, 21410340, 21410341, 21410342, 21410345, 22410022, 22410023, SN0410157, SN1410049, SN19410034, SN19410035, SN19410036, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410129, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, SN20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410555, SN20410556, SN20410557, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410094, SN21410099, SN21410103, SN21410104, SN21410105, SN21410117, SN21410118, SN21410119, SN21410130, SN21410131, SN21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, SN21410213, SN21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, and SNZY204110015.
Distribution pattern: US Nationwide distribution. There was government distribution but no military distribution.
Derived failure modes
-
Unknown
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.