Health product recall

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

  1. Dimension EXL Analyzer with LM
  2. Dimension EXL 200 Analyzer
  3. 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

  1. 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