# FDA recall Z-0209-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-08-14.

## Product

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0209-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-14
- **Report date:** 2018-10-31
- **Termination date:** 2020-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0209-2019

## Citation

> AI Analytics. FDA recall Z-0209-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0209-2019. Source: US FDA. Licensed CC0.

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