Biograph mMR System (2020-04-30)

Starting date:

April 30, 2020

Posting date:

May 15, 2020

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-73105

Last updated: 2020-05-15

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  Reason
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  Affected products

Affected Devices

Biograph mMR System

Reason

This update provides a software update to N4 VE11P-SP04, which resolves the following issues and prevents them from recurring. The update is not providing new features or new functionality. These fixes do not affect patient safety.

• Patient ID and name were not anonymized in error cases.
• Improved service online help and online maintenance instruction (only for service)
• Added features and options already available with AP01: CP/EP mode & new option on the contrast - common parameter card

Affected products