Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 5/15/2019
Class II
PRODUCT
Atellica IM 1300 Analyzer, Material Number 11066001; Recall Number: Z-1299-2019
Atellica IM 1600 Analyzer, Material Number 11066000; Recall Number: Z-1300-2019
Atellica Sample Handler Prime, Material Number 11069001; Recall Number: Z-1301-2019
REASON
There were multiple issues identified in the system software which required an update.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. on 3/7/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
277
DISTRIBUTION
US Nationwide and International