FDA Device Recall Z-0083-2015: Siemens Healthcare Diagnostics, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0083-2015.

Recall Res Number

Z-0083-2015

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc

FEI Number

1219913

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-09-19

Date Posted

2014-10-17

Date Terminated

2015-07-20

Product Code

JIL

Event Number

69228

Product Quantity

approx. 4200

Product Description External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.

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 Details 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.

Distribution Pattern Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally Canada, Mexico, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Tadjikistan, Taiwan, Turkey, Turkmenistan, Unit.Arab Emir., United Kingdom, Vietnam.

Code Information / Serial Numbers 10378632, 10378633, 10378634, 10309177, 10309178, 10324040, 10376820 Power supply adaptors embossed with the following numerical date codes: 50130, 51130, 52130, 01140, 02140, 03140, 04140, 05140, 06140, 07140, 08140, 09140, 10140, 11140, 12140, 13140, 14140, 15140, 16140, 17140, 18140, 19140, 20140, 21140, 22140, 23140

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Medical Device Recall: Z-0083-2015

Recall Parameters & Description

Related Establishments / Registrations

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