Recall Z-0083-2015— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0083-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-19

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-09-19, terminated 2015-07-20. It names one FDA 510(k) clearance: K091216. Product: External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-09-19
Terminated: 2015-07-20
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K091216 — CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797Siemens Healthcare Diagnostics·cleared 2009-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.