FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
- Recall number
- Z-0148-2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
- Status
- Terminated
- Initiated
- 2019-07-30
- Posted
- not on file
- Terminated
- 2022-06-10
- Reason
- Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
- Root cause
- Software design
- Action
- Siemens issued an Urgent medical Device Correction, (UMDC ASI19-02.A.US) via Fed Ex and Urgent Field Safety Notification (UFSN ASI19-02.A.OUS) to all affected Customers beginning on 2019-07-30. The UFSN/UMDC explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email within 30 days. Field Service personnel will be sent a Service Knowledge Base describing the issue and instructing them how to deal with customer questions.
- Quantity
- 1125 units
- Distribution
- Worldwide Distribution - US Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Brazil Bulgaria Canada Chile Colombia Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Hungary India Indonesia Iran Ireland Israel Italy Japan Kuwait Latvia Malaysia Mexico Netherlands Nigeria Norway P.R. China Pakistan Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
- Lot, serial or model codes
- Software version: V1.19.2 and below
- 510(k) numbers
- ["K151767"]
- PMA numbers
- not on file
- Product code
- JGS
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28