Recall – IVD analyzer software errors may result in incorrect patient results

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 1/20/2021
Class II

PRODUCT

Atellica CH 930 Analyzer – In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 – Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

Recall Number: Z-0861-2021

REASON

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc. on 12/2/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2405 units

DISTRIBUTION

U.S. Nationwide and International

Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.