Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 recallZ-0205-2020 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 15, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens issued an Urgent Medical Device Correction (UMDC) to US customers via FedEx on August 15, 2019. The UFSN was electronically issued to all OUS Siemens sites, with affected customers, for distribution, as well as regional reporting to their respective local competent authority on August 16, 2019. The UMDC/UFSN explain the behavior(s) to users and provide actions to be taken to correct the behavior. Customers are requested to return the Effectiveness Check Form, in the UMDC/UFSN via fax or email. Siemens Healthcare Diagnostics Inc. has released an updated software (SW) version (V) 1.20.0, which corrects the reported behavior(s). A Mandatory Update (MU) campaign has been launched to install the new SW V on all systems, whether or not they are impacted by these behaviors.
Recall details
- Recall number
- Z-0205-2020
- Status
- Terminated
- Initiated by the company
- Aug 15, 2019
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 166 total US: 15; OUS:151
- Product code
- JJE
- FDA submissions
- K151792
- Distribution
- Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam
Product description
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Code information (models, lots, serial numbers)
(SW) version V1.19.0 and V1.19.2 UDI: 00630414002026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atellica IM 1600 Analyzer 11066000Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE7 recalls196 reports
Other devices under the same FDA submission
1 device cleared under K151792 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Atellica IM 1300 Analyzer 11066001Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE6 recalls188 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 83655).
- Z-0204-2020 · TerminatedAtellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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