Siemens StreamLab Automation Modules Recalled for Missing Pacemaker Warning Label
Siemens Healthcare Diagnostics is recalling 186 StreamLab Automation Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.
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 risk of harm to pacemaker functionality, which is a high-risk hazard, but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 186 StreamLab Automation Modules (Core Unit / Lynx with IOM). The recall was initiated because the modules may have been shipped without a required warning label indicating a potential risk of interference to pacemaker functionality.
The affected products were distributed to numerous US states, including Alabama, Arizona, California, Florida, New York, and Texas, as well as to various foreign countries such as Australia, Canada, Germany, and the United Kingdom. The specific Siemens Material Number for the affected units is 10444806, and the UDI is 00630414949765.
Healthcare facilities and consumers who possess these modules should contact Siemens Healthcare Diagnostics for further instructions on how to obtain the appropriate warning label or replace the affected units.
The recalled product
- Product
- STREAMLAB CORE UNIT / LYNX WITH IOM
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 186
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 (2)
- Siemens Material Numbers: 10444806
- UDI: 00630414949765
Distribution
Part of a larger recall action
This product is one of 9 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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