MAGNETOM Prisma and Prisma Fit (2018-12-11)

Starting date:

December 11, 2018

Posting date:

January 8, 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-68696

• 
  Reason
• 
  Affected products

Affected products

1. MAGNETOM Prisma Fit
2. MAGNETOM Prisma

Reason

Siemens has identified a software update in order to fully satisfy the IEC 60601-2- 33 standard. This standard defines a limit to avoid cardiac stimulations incorporating a well-spaced safety factor. With the currently installed MAGNETOM Prisma software, this given limit may be exceeded in rare cases.

Affected products