Data Foundry

Medical device recalls 2020

Siemens Aptio Automation Centrifuge Module — Class II medical device recall Z-1889-2020

Ongoing recall by Inpeco S.A., reported 2020-05-13, distributed in AL, CA, CT, DE, FL, IA, KY, LA…. The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge

Recall numberZ-1889-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmInpeco S.A., Lugano, N/A, Switzerland
Recall initiated2020-04-07
Classified2020-05-05
Reported by FDA2020-05-13
DistributedAL, CA, CT, DE, FL, IA, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, TN, TX, VA, WA
Countries outside the USMX
Quantity313
Reason classessoftware
Serial numbersAP2.0001, AP2.0002, AP2.0005, AP2.0008, AP2.0010, AP2.0011, AP2.0012, AP2.0013, AP2.0014, AP2.0016, AP2.0018, AP2.0019, AP2.0023, AP2.0024, AP2.0025, AP2.0026, AP2.0027, AP2.0032, AP2.0033, AP2.0034, AP2.0036, AP2.0039, AP2.0041, AP2.0042, AP2.0044 and 288 more

Product

Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

Reason for recall

The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

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-1889-2020. 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.