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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Dimension systems

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  Class 2 Device Recall Siemens Dimension systems see related information
Date Initiated by Firm September 28, 2018
Create Date November 09, 2018
Recall Status1 Terminated 3 on June 17, 2020
Recall Number Z-0409-2019
Recall Event ID 81278
510(K)Number K130276  K112999  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Dimension Thermal Chamber Motor Cable located in the following models:
Model/UDI Number:
Dimension¿ EXL 200 00630414593579;
Dimension¿ EXL with LM 00630414593500;
Dimension¿ EXL with LM with STM 00630414593593;
Dimension¿ RxL Max 00630414949789;
Dimension¿ RxL Max HM 00630414949796;
Dimension¿ RxL Max HM STM 00630414949819;
Dimension¿ Xpand¿ Plus 00630414949833;
Dimension¿ Xpand¿ Plus HM 00630414949840;
Dimension¿ RxL Max Refurbished 00630414592947;
Dimension¿ RxL Max HM Refurbished 00630414592954;
Dimension¿ Xpand¿ Plus Refurbished 00630414592961;
Dimension¿ Xpand¿ Plus HM Refurbished 00630414592978;
Dimension¿ EXL with LM Refurbished 00630414000268;
Dimension¿ 200 Refurbished 00630414010717;;
Dimension¿ RxL Max w/o HM International 00630414949802;
Dimension¿ RxL Max HM International 00630414945477;
Dimension¿ RxL Max HM STM International 00630414949826;
Dimension¿ Xpand Plus w/o HM International 00630414949857;
Dimension¿ Xpand Plus w/HM International 00630414945484;
Dimension¿ EXL with LM International 00842768030024;
Dimension¿ EXL 200 International 00842768037214
Dimension¿ EXL with LM with STM International 00630414593609

The Dimension motor assembly is used in the Dimension Thermal Chamber Fan (ASSY BLOWER SNOUT) and is responsible for the intake and circulation of air inside the "Wok," a chamber within the Dimension instrument which enables greater temperature control of the testing environment.
Code Information Model/UDI: Dimension¿ EXL 200 00630414593579 Dimension¿ EXL with LM 00630414593500 Dimension¿ EXL with LM with STM 00630414593593 Dimension¿ RxL Max 00630414949789 Dimension¿ RxL Max HM 00630414949796 Dimension¿ RxL Max HM STM 00630414949819 Dimension¿ Xpand¿ Plus 00630414949833 Dimension¿ Xpand¿ Plus HM 00630414949840 Dimension¿ RxL Max Refurbished 00630414592947 Dimension¿ RxL Max HM Refurbished 00630414592954 Dimension¿ Xpand¿ Plus Refurbished 00630414592961 Dimension¿ Xpand¿ Plus HM Refurbished 00630414592978 Dimension¿ EXL with LM Refurbished 00630414000268 Dimension¿ 200 Refurbished 00630414010717 Dimension¿ RxL Max w/o HM International 00630414949802 Dimension¿ RxL Max HM International 00630414945477 Dimension¿ RxL Max HM STM International 00630414949826 Dimension¿ Xpand Plus w/o HM International 00630414949857 Dimension¿ Xpand Plus w/HM International 00630414945484 Dimension¿ EXL with LM International 00842768030024 Dimension¿ EXL 200 International 00842768037214 Dimension¿ EXL with LM with STM International 00630414593609  Serial Numbers: Serial Numbers to be Inspected 221106 973106 223948-X 224328-AX 972332W-AX 2004070479 2004071143 2004071701 2004072659 2004072983 2001082078 2004080191 2004080512 2004081060 2004081428 2004081859 2004082188 2004082216 2004082330 2004083044 2001070108W 2004070588 2004070601 2004071727 2004073029 2004080889 2004080423 2004081647 2004081901 2004082008 2004082292 2004082379 2004082497 2004082823 2004083030 972004-X 221635-AX 220101-AX 220606-AX 220705-AX 220719-AX 220960-AX 222144-AX 222916-AX 223104-AX 223113-AX 223122-AX 972359W-AX 2001080164W 2001081187 2001081262 2004071443 2001081370W 2001081491 2004080946 2004081615 2004081660 2004081774 2004081828 2004082208 2004082330 973091W-AX 2001080169 2001081363 2001081485 971958W-X 972295W-AX 2001072014 12251163 12251392 12251525 12251745 12251789 12251798 12251895 12252027 12252285 12252523 12252560 12252821 DR250141 DR251512 12251570 12251874 12251902 12251969 12252078 12252097 12252157 12252242 12252327 12252328 12252353 12252360 12252380 12252525 12252671 12252673 12252741 12252767 12252805 12252807 12252827 12252881 12252886 DE230279B0 DE230321B0 DR251508 DR251510 DR251511 DR251513 DR251514 DR251515 DR251516 DR251517 DR251518 DR251519 DR251522 DR251523 DR251525 DR251526 DR251527 DR251532 DR251533 DR251534 DR251535 DR251542 DR251544 DE270132 DE270355 DE270423 DE270528 DE270729 DE270832 DE270889 DE271009 DE271163 DE271207 DE271256 DE271388 DE271611 DE271793 DE271838 DE271957 DE271966 DE272298 DR271533 DR271534 DR271542 DR271563 DR271567 DR271568 DR271569 DR271570 DR271575 DR271577 DR271578 DR271579 DR271581 DR271588 DR271590 DR271591 DR271599 DR271604 DR271605 DR271615 DR271619 DR271632 DR271634 DR271636 DR271650 DE270248 DE270303 DE270415 DE270562 DE270569 DE270650 DE270769 DE270891 DE270908 DE270954 DE270972 DE271004 DE271098 DE271179 DE271239 DE271339 DE271368 DE271372 DE271400 DE271447 DE271452 DE271499 DE271580 DE271584 DE271637 DE271854 DE271872 DE271881 DE271896 DE272098 DE272215 DE272377 DR270436 DR271525 DR271526 DR271527 DR271528 DR271529 DR271530 DR271532 DR271538 DR271539 DR271541 DR271544 DR271545 DR271548 DR271551 DR271552 DR271559 DR271561 DR271562 DR271583 DR271585 DR271586 DR271594 DR271595 DR271596 DR271597 DR271601 DR271602 DR271603 DR271606 DR271607 DR271611 DR271641 DE260110 DE271199 DE272562 12251162 12251415  
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Newark DE 19702-2466
For Additional Information Contact SAME
800-441-9250
Manufacturer Reason
for Recall		 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 that could result in a potential electrical shock
FDA Determined
Cause 2		 Device Design
Action The firm, Siemens Healthcare, issued on 09/28/2018, "Urgent Medical Device Correction" DI-18-02.A.US (US customers)/Urgent Field Safety Notice DI-18-02.A.OUS ( for OUS customers), informing them of the issue and providing them with the steps Siemens is taking to correct the issue. A Siemens Service Engineer will schedule a Service visit to inspect the instrument and install a protective cover, if necessary, to correct the issue. Customers were instructed to perform the following actions: "Please arrange a time for your system upgrade when contacted by Siemens. "Return completed Field Correction Effectiveness Form to Siemens Healthcare Diagnostics via fax to the Customer Care Center  Technical Solutions at 312-275-7795 or please send a scanned copy of the completed form via email to uscctsfcaecfax.team@siemens-healthineers.com. "retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center, your local Siemens Technical Support Representative or the Quality Engineer QT, LD, Commercial Product Quality at 302-631-0528 or email: richard.andersen@siemens-healthineers.com.
Quantity in Commerce 277 units
Distribution Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Brazil, Canada, China, Columbia, Croatia, Egypt, France, Germany, Great Britain, Greece, Hungary, India, Italy, Japan, Malaysia Mexico, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Tanzania, Thailand, Tunisia, Turkey, and United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
510(K)s with Product Code = JJE and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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