Sophycamera Dsx Bodytrak

• • Ongoing Z-1046-2026 FDA Class II ·initiated 10 Dec 2025

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

510(k) Number

K911346 ↗

FDA Product Code

IYX

Device Class

Class I

Regulation

21 CFR Part 892.1100

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Vector Series

  Class II

  FDA 510(k) K921008 Active Cleared 27 Apr 1992

• Dst-Xl

  Class II

  FDA 510(k) K942837 Active Cleared 5 Jan 1995

• Sophy Nxt

  Class II

  FDA 510(k) K913641 Active Cleared 17 Dec 1991

• Transmission Attenuation Correction (TAC) Package

  Class II

  FDA 510(k) K952190 Active Cleared 18 Jan 1996

• Sophy Series of Nuclear Medicine Computer Systems

  Class I

  FDA 510(k) K872132 Active Cleared 26 Oct 1987

• Ds-7 Nuclear Medicine Gamma Camera

  Class I

  FDA 510(k) K872297 Active Cleared 12 Aug 1987

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