MobileDiagnost wDR (2019-03-25)

Starting date:

March 25, 2019

Posting date:

April 18, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69632

Last updated: 2019-04-18

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  Reason
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  Affected products

Affected Products

MobileDiagnost wDR

Reason

1. Unexpected movement may occur while driving the system. The system may exhibit unintended movement which can only be stopped by engaging the emergency stop. In certain circumstances the system may exhibit erratic movement which is stopped by releasing the deadman switch.
2. Similar issues may be present in cases where the drive handle bar is sticking (for instance because it is not adjusted correctly), this can cause movement to continue unintended and it can only be stopped by engaging the emergency stop button.

Affected products