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External power supply adaptors that accompany Clinitek… recallZ-0081-2015 · Siemens Healthcare Diagnostics, Inc · initiated Sep 19, 2014

Class II Terminated All recalls posted in October 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0081-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 19, 2014
Posted by the FDA
Oct 17, 2014
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
approx. 4200
Product code
JIL
FDA submissions
K091216
Distribution
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.

Product description

External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.

Code information (models, lots, serial numbers)

10379675, 10379676, 10379677, 10379678, 10379679, 10379680, 10379681, 10376324; (Legacy P/N: 1780) 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

Other devices under the same FDA submission

2 devices cleared under K091216 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 69228).

Sources and updates

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