Siemens APTIO Rack Output Module Recall for Missing Warning Label
Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Output Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 441 APTIO Rack Output Modules. The recall is due to the possibility that the modules were 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 10715432 and 10715434, and the UDI is 00630414594477.
Consumers and healthcare facilities should check their inventory for these specific material numbers and UDI codes. If the modules are found, they should contact Siemens Healthcare Diagnostics for instructions on how to proceed.
The recalled product
- Product
- APTIO RACK 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 (3)
- Siemens Material Numbers: 10715432
- 10715434
- 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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