STREAMLAB CORE UNIT / LYNX WITH IOM — Class II medical device recall Z-0215-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-10-31, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. The modules may have been shipped without a warning label for potential risk of interference to pacemaker func
| Recall number | Z-0215-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2018-08-14 |
| Classified | 2018-10-23 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-09-04 |
| Distributed | 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, WV |
| Countries outside the US | AE, AT, AU, BD, BE, CA, DE, ES, FR, GB, GR, HK, HR, ID, IN, IT, NL, PH, PT, SA, SI, SK, TW |
| Quantity | 186 streamlab |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00630414949765 |
Product
STREAMLAB CORE UNIT / LYNX WITH IOM
Reason for recall
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0215-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.