External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status syst

FDA device recall Z-0083-2015 · posted 2014-10-17 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

Action taken

Siemens sent an Urgent Field Safety Notice dated September 2014, to all by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on September 19, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the power supply and the potentially affected products that may contain a damaged power supply. Consignees are asked to complete a Field Correction Effectiveness Check form and return in to Siemens Healthcare Diagnostics via Fax to (312) 275-7795. All affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on 9/23/14. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. Customers with questions were instructed to contact their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.

Root cause

Process control

Status

Terminated

Product code

JIL

Quantity affected

approx. 4200

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally Canada, Mexico, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech

Date initiated

2014-09-19

Date posted

2014-10-17

Date terminated

2015-07-20

Location

East Walpole, MA

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