Siemens APTIO Rack Input Module Recall for Missing Pacemaker Warning
Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Input 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 medical device with a potential risk of interference to pacemaker functionality, which is a high-risk hazard where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 441 APTIO Rack Input 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 U.S. states and 26 foreign countries. The specific Siemens Material Numbers involved are 10703037 and 10711144, and the UDI is 00630414594477.
Healthcare facilities and users should check their inventory for these specific material numbers and UDI. If the modules are found, they should contact Siemens Healthcare Diagnostics for instructions on how to proceed, as the missing label may affect the safety of patients with pacemakers.
The recalled product
- Product
- APTIO RACK INPUT 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: 10703037
- 10711144
- 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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