Recall Z-0216-2019— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0216-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-14

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-08-14, terminated 2020-09-04. It names one FDA 510(k) clearance: K082638. Product: STREAMLAB - REFRIGERATED STORAGE MODULE 9000. Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-14
Terminated: 2020-09-04
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.·cleared 2009-02-26

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

STREAMLAB - REFRIGERATED STORAGE MODULE 9000

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

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