Zoom Latitude Programmer/Recorder/Monitor (2019-08-21)

Starting date:

August 21, 2019

Posting date:

August 30, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70861

Last updated: 2019-09-05

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  Reason
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  Affected products

Affected Products

Zoom Latitude Programmer/Recorder/Monitor

Reason

Improper software configuration. There were some required software patches that were excluded and some that had extra software added. The improper software is only applicable to certain older pulse generator families, which have not been distributed for over 5 years. The improper software configuration was identified during an internal inspection process. There is no patient risk and no patient harm has been reported to date or is likely to occur.

Affected products