Dimension EXL Analyzer with LM, Dimension EXL 200 Analyzer, and Dimension RxL Max w/HM Analyzer (2018-10-04)
- Starting date:
- October 4, 2018
- Posting date:
- October 26, 2018
- 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-68082
Affected products
- Dimension EXL Analyzer with LM
- Dimension EXL 200 Analyzer
- Dimension RxL Max w/HM Analyzer
Reason
Siemens has identified that some thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation. The thermal chamber motor is located under the thermal chamber within the dimension instrument and can be accessible when changing the thermal chamber filter.
Affected products
-
Dimension EXL Analyzer with LM
Lot or serial number
- 12252027
- 12252523
Model or catalog number
- 759020.911
- 778020.911
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
B. Dimension EXL 200 Analyzer
Lot or serial number
- DR271567
- DR271577
- DR271578
- DR271619
Model or catalog number
- 778041.911
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
C. Dimension RxL Max w/HM Analyzer
Lot or serial number
- 220686
Model or catalog number
- 752000.911
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES