Data Foundry

Medical device recalls 2014

GEMINI TF Big Bore PET/CT — Class II medical device recall Z-0979-2014

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-02-19, distributed in AR, CA, CO, FL, IL, LA, MA, MD…. The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an au

Recall numberZ-0979-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Medical Systems (Cleveland) Inc, Cleveland, OH, United States
Recall initiated2013-12-05
Classified2014-02-12
Reported by FDA2014-02-19
Terminated2015-08-25
DistributedAR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT, WI
Countries outside the USBE, CA, CN, DE, DK, FR, IT, JP, NL, SA, VE
Quantity47 units
Serial numbers9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206 and 22 more
Model numbers882476

Product

GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

Reason for recall

The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.

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-0979-2014. 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.