Z-0211-2019 Class II Terminated
FDA device recall Z-0211-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on Aug 14, 2018 and is designated Class II. Reason for recall: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. The recall status is terminated (terminated Sep 4, 2020). Affected quantity: 441 Aptio Automation Modules.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2018
- Initiation Date
- Aug 14, 2018
- Termination Date
- Sep 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 441 Aptio Automation Modules
Product Description
Reason for Recall
Distribution Pattern
The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0211-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026