Siemens APTIO 15000 Refrigerated Storage Module Recall for Missing Warning Label
Siemens Healthcare Diagnostics is recalling 441 APTIO 15000 Refrigerated Storage 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 (interference with pacemaker functionality) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 441 APTIO 15000 Refrigerated Storage 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 numerous US states, including Alabama, Arizona, California, Florida, New York, and Texas, as well as to foreign countries such as Canada, Germany, and the United Kingdom. The specific Siemens Material Numbers associated with the recall are 10703036 and 10713762, and the UDI is 00630414594477.
Healthcare facilities and consumers should check their inventory for these specific material numbers and UDI codes. If the modules are found, they should be removed from use and returned to Siemens Healthcare Diagnostics, Inc. according to the company's instructions.
The recalled product
- Product
- APTIO 15000 REFRIGERATED STORAGE 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: 10703036
- 10713762
- 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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