Discovery Model Nm/CT 670

• 4 recalls, same reason

  • Ongoing Z-0895-2025 FDA Class II ·initiated 18 Dec 2024
  • Ongoing Z-0894-2025 FDA Class II ·initiated 18 Dec 2024
  • Ongoing Z-0893-2025 FDA Class II ·initiated 18 Dec 2024
  • Ongoing Z-0891-2025 FDA Class II ·initiated 18 Dec 2024

  GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

• • Ongoing Z-1053-2023 FDA Class I ·initiated 19 Dec 2022

  A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

• • Ongoing Z-1547-2021 FDA Class II ·initiated 7 Feb 2021

  GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

• • Terminated Z-0857-2021 FDA Class II ·initiated 10 Dec 2020

  GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

• 3 recalls, same reason

  • Terminated Z-2998-2020 FDA Class II ·initiated 14 Aug 2020
  • Terminated Z-2996-2020 FDA Class II ·initiated 14 Aug 2020
  • Terminated Z-2997-2020 FDA Class II ·initiated 14 Aug 2020

  Rotor bearing screws were found loose on detector.

• 3 recalls, same reason

  • Terminated Z-1260-2019 FDA Class II ·initiated 20 Mar 2019 ·on shared 510(k) K093514
  • Terminated Z-1259-2019 FDA Class II ·initiated 20 Mar 2019 ·on shared 510(k) K093514
  • Terminated Z-1265-2019 FDA Class II ·initiated 20 Mar 2019 ·on shared 510(k) K093514

  During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

• 3 recalls, same reason

  • Completed Z-0606-2019 FDA Class II ·initiated 24 May 2018
  • Completed Z-0607-2019 FDA Class II ·initiated 24 May 2018
  • Completed Z-0608-2019 FDA Class II ·initiated 24 May 2018

  When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.

• • Terminated Z-2194-2017 FDA Class II ·initiated 19 May 2017

  It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

• • Terminated Z-0367-2014 FDA Class II ·initiated 25 Oct 2013

  GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a

• • Terminated Z-1792-2013 FDA Class I ·initiated 13 Jun 2013

  GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re

• • Terminated Z-0121-2013 FDA Class II ·initiated 12 Oct 2012

  GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and

• • Terminated Z-1110-2012 FDA Not yet classified ·initiated 11 Jan 2012

  GE Healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of your Discovery NM/CT 670 and/or Discovery NM 630 system that may impact operator safety. 1. The cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. 2. Another issue is that the

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K093514 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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