Atellica IM 1300 Analyzer — Class II medical device recall Z-1299-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-05-15, distributed in AL, AR, AZ, CA, CO, FL, GA, IL…. There were multiple issues identified in the system software which required an update.
| Recall number | Z-1299-2019 |
|---|---|
| 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 | 2019-03-07 |
| Classified | 2019-05-09 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2020-08-20 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, UT, WA, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GR, HR, HU, IE, IL, IN, IT, JP, KR, LV, MX, MY, NG, NL, NO, PK, PL, PT, SA, SE, SG, SK, TH, TR, VN, ZA |
| Quantity | 277 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00630414007960 |
Product
Atellica IM 1300 Analyzer, Material Number 11066001
Reason for recall
There were multiple issues identified in the system software which required an update.
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-1299-2019. 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.