MultiDiagnost-ELEVA, OmniDiagnost Systems (2019-03-03) — recall 59526
Health Canada — Medical Devices · Canada · 2019-03-15 · Type II
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Reported risk: For the height and tilt movement of the stand/table, the MultiDiagnost-ELEVA, OroDiagnost and OmniDiagnost systems have 2 actuators that are connected to the system stand by 4 shafts. The position of each of these shafts is secured by a locking plate. During service of two MultiDiagnost-ELEVA systems, it was noticed that a locking plate was missing. In one of these cases, the shaft was still properly positioned after the system had been in use for 9 years. In the other case, involving a system that had been in use for 5 years, the shaft was no longer properly positioned but was still holding the actuator. Over time, a missing locking plate may result in the shaft of the corresponding connection point becoming improperly positioned. If the shaft works its way totally out of position, it could result in unexpected stand/table tilt movement that cannot be stopped by the user.
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