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FDA (Device enforcement)Recalled 2018-11-30class ii

GE Healthcare, LLC: System, Tomography Computed Emmission

Is my product affected?

System, Tomography Computed Emmission

  • UPC 000000109961

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare recalled a small number of Discovery NM 530c Nuclear Medicine systems that were operating with outdated software. One patient's finger was injured during the automatic Unload process on a system with non-current software. A total of 526 units were affected across numerous states in the United States and multiple countries internationally.

The recall record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

Details from the source

Reason for recall: GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current. Distribution: Domestic Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, IA, IL, IN, KY, LA,MA, MD, ME, MI, MN, MO, MS, NC, NE, NM, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT,VA, WI and WV. Foreign Distribution: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Ghana, India, Israel, Italy, Japan, Korea, Malaisya, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Quantity: 526 total units Lot/code info: Model for Discovery NM 530c: 5248934, 5166674-01, H3000SA, H3001JA, H3001JD. Serial Numbers: 19016,0000000ME11041,19069,19098,19082,19070,19086,19027,19044,19083,19065,19062,19048,19009,19109,19015,19040,19085,19012, 19108, 19030, 19057,000000109961-1,19002,16001,16007,19008,19097,19072,19080,16020,19026,19005,19025,0000000000ME-4.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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