Siemens APTIO Input/Output Modules Recalled for Missing Pacemaker Warning Label
Siemens Healthcare Diagnostics is recalling 441 APTIO Input/Output 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 product (potential pacemaker interference) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 441 APTIO Input/Output Modules. The recall was initiated because the modules may have been shipped without a warning label indicating a potential risk of interference to pacemaker functionality.
The affected products were distributed to 38 US states and 25 foreign countries. The specific Siemens Material Numbers involved are 10703031, 10713760, 10713775, and 10713772, with UDI 00630414594477.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled modules or what immediate actions to take.
The recalled product
- Product
- APTIO INPUT/OUTPUT MODULE
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 441
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 (5)
- Siemens Material Numbers: 10703031
- 10713760
- 10713775
- 10713772
- UDI: 00630414594477
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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