GE Medical Systems Israel recalls Infinia, Infinia Hawkeye, Infinia II, and Infinia II Hawkeye 4 nuclear medicine systems with incorrect gantry software that may cause life-threatening injury during patient scans.
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
GE Medical Systems Israel is recalling certain Infinia and Infinia Hawkeye nuclear medicine systems that may have unintended detector motion during patient scans if the gantry software is not correctly installed. This could result in life-threatening injury.
The system may move detectors unexpectedly during patient setup or scanning if the gantry software version is incorrect. This unintended motion could cause serious injury or death to the patient.
Healthcare facilities using the recalled Infinia, Infinia Hawkeye, Infinia II, or Infinia II Hawkeye 4 nuclear medicine systems with the listed serial numbers are affected. Patients undergoing scans with these systems are at risk of life-threatening injury.
Check if your system is an Infinia, Infinia Hawkeye, Infinia II, or Infinia II Hawkeye 4 nuclear medicine system with one of the serial numbers listed in the recall notice. The serial numbers are provided in the recall record.
Immediately stop using the recalled nuclear medicine system if it has the listed serial numbers.
The recall affects Infinia, Infinia Hawkeye, Infinia II, and Infinia II Hawkeye 4 nuclear medicine systems with specific serial numbers listed in the recall notice.
Check your system's serial number against the list of affected serial numbers provided in the recall notice.
The risk is unintended detector motion during patient setup or scanning, which could result in life-threatening injury.
We’ve drafted a message you can send GE Medical Systems Israel to request your refund or repair — edit it as you like.
Subject: Recall Z-2097-2025 — GE Medical Systems Israel GE Medical Systems Israel Hello, I own a GE Medical Systems Israel that is covered by recall Z-2097-2025 from GE Medical Systems Israel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
