Recall Z-0209-2019— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-08-14, terminated 2020-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: APTIO INPUT/OUTPUT MODULE. Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-14
- Terminated
- 2020-09-04
- Firm location
- Tarrytown, NY, United States
Product description
APTIO INPUT/OUTPUT MODULE
Reason for recall
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Data sourced from openFDA. This site is unofficial and independent of the FDA.