FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: Atellica IM 1600 Analyzer, SMN 11066000
- Recall number
- Z-0125-2022
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- Atellica IM 1600 Analyzer, SMN 11066000
- Status
- Open, Classified
- Initiated
- 2021-09-28
- Posted
- not on file
- Terminated
- not on file
- Reason
- Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
- Root cause
- Under Investigation by firm
- Action
- On September 27, 2021, the firm initiated notifications to affected customers. Customer distribution included all customers located in a city at an altitude of 350 meters (1148 feet) or higher. Customers were informed that Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350 (m) or 1148 (ft) above sea level. The letters provide directions for mitigating the potential for leakage. If you have any questions, contact your local Siemens Healthineers technical support representative.
- Quantity
- 1733
- Distribution
- Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K151792"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28