FDA Recall Terminated

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.

Recall: Z-0409-2019 · Initiated September 28, 2018

Recall

Recall Number: Z-0409-2019
Event Number: 81278
Firm: Siemens Healthcare Diagnostics, Inc.
FEI Number: 2517506
Product Code: JJE
Status: Terminated
Root Cause: Device Design
Initiated: September 28, 2018
Terminated: June 17, 2020
Address: 500 Gbc Dr Ms 514, Newark, DE, 19702-2466

Description

Reason

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

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 [email protected]. "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: [email protected].

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.

Quantity

277 units