Dimension Xpand System - Xpand Plus, Dimension EXL Analyzer with LM, Dimension EXL 200 Analyzer, Dimension Xpand System - Xpand Plus with HM Analyzer, Dimension RXL Max W/HM Analyzer (2019-04-07)
- Starting date:
- April 7, 2019
- Posting date:
- May 3, 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-69822
Last updated: 2019-05-03
Affected Products
A. Dimension Xpand System - Xpand Plus
B. Dimension EXL Analyzer with LM
C. Dimension EXL 200 Analyzer
D. Dimension Xpand System - Xpand Plus with HM Analyzer
E. Dimension RXL Max W/HM Analyzer
Reason
Siemens Healthcare Diagnostics has identified the following three Dimension software version 10.3 behaviors inconsistent with expectations. Dimension software version 10.3 contains product improvements including enhanced security features as well as upgrade capabilities required for future software versions to be installed. All Dimension customers will receive software version 10.3. The unintended behaviors indicated in this letter do not impact the accuracy of patient results and will be corrected in the next version of dimension software currently being developed.
Affected products
A. Dimension Xpand System - Xpand Plus
Lot or serial number
2004080889
2004081061
2004081160
Model or catalog number
765000.921
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES
B. Dimension EXL Analyzer with LM
Lot or serial number
12251747
12251791
12251797
12251965
12252005
12252027
12252113
12252114
12252139
12252422
12252429
12252468
12252520
12252523
12252559
12252622
12252682
12252687
12252762
12252786
12252790
12252818
DR250262
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
C. Dimension EXL 200 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
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
D. Dimension Xpand System - Xpand Plus with HM Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
765000.931
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES
E. Dimension RXL Max W/HM Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
752000.911
752000.931-R
752000.941
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES