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
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
Biograph mMR System
Lot or serial number
- 151014
- 151022
- 51018
- 51060
- 51068
Model or catalog number
- 10433372
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY