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.
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, 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.
See all 9 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · electromagnetic interference
See all →- HighSix foot display cables recalled over inadequate shielding and interference
FDA (Devices) · 2025-10-22
- HighTwelve foot display cables recalled over inadequate shielding and interference
FDA (Devices) · 2025-10-22
- HighMonitor display cables recalled over inadequate shielding and electromagnetic interference
FDA (Devices) · 2025-10-22
- HighOperating tables recalled because interference can leave them unresponsive to controls
FDA (Devices) · 2025-09-03
- HighOlympus Quest Spectrum 3 Fluorescent Imaging System Recalled for EMC Defect
FDA (Devices) · 2024-11-06
Similar recalls
- SevereSiemens Aptio Automation Modules Recalled for Overheating Power Cord Plugs
FDA (Devices) · 2016-11-23
- HighSiemens Hettich Centrifuge Modules Recalled for Premature Bucket Failures
FDA (Devices) · 2016-07-06
- ModerateSiemens FlexLab Automation Modules Recalled for Potential Safety Concerns
FDA (Devices) · 2016-11-23
- ModerateAbbott APS Accelerator Modules Recalled for Missing Pacemaker Safety Label
FDA (Devices) · 2019-10-02
- ModerateSiemens Atellica Sample Handler Prime Recalled for Software Issues
FDA (Devices) · 2019-05-15
- ModerateSiemens Recalls ADVIA Centaur BRAHMS PCT 100 Test Kits Due to Interference
FDA (Devices) · 2014-06-04