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