Recall Z-1299-2019— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1299-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-07

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2019-03-07, terminated 2020-08-20. It names one FDA 510(k) clearance: K151792. Product: Atellica IM 1300 Analyzer, Material Number 11066001. Reason: There were multiple issues identified in the system software which required an update..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Terminated: 2020-08-20
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K151792 — Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc.·cleared 2015-11-20

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

Atellica IM 1300 Analyzer, Material Number 11066001

Reason for recall

There were multiple issues identified in the system software which required an update.

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