Siemens Atellica IM 1600 Analyzer Software Recall for Discrepant Results
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where software defects may lead to discrepant patient results, representing a risk of harm where specific injuries have not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,588 units of the Atellica IM 1600 Analyzer. These devices are intended for the qualitative and quantitative analysis of various body fluids using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
The recall is due to multiple issues in software version 1.23.2 (SMN 11469032) or lower that may lead to the reporting of discrepant patient results. The affected units were distributed worldwide, including in the United States and numerous other countries.
Healthcare facilities and users should contact Siemens Healthcare Diagnostics for instructions on how to address the software issues and ensure accurate patient results.
The recalled product
- Product
- Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and i
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,588
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software (SW) versions V1.23.2 (SMN 11469032) or lower
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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