The Recall Desk
HighFDA (Devices)·Z-1511-2022·Announced 2022-08-17

GE Healthcare CT, PET, and NM Patient Tables May Drop During Service

GE Healthcare patient tables used in CT, PET, and NM systems can drop during service if technicians remove incorrect screws without appropriate supports, potentially injuring service personnel.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving risk of serious injury (table drop hazard) to service personnel during maintenance activities. The source text does not report any documented injuries or hospitalizations, placing this at the 'risk-of-harm products where injury has not yet been reported' level per the rubric.

Plain-English summary

This recall affects service manuals for GE Healthcare patient tables used in CT, PET, and NM imaging systems, including models such as GT1700, GT2000, Discovery, Optima, Revolution, and others. Approximately 24,843 tables are subject to this recall. The devices were distributed nationwide in the United States and Puerto Rico, with additional distribution to U.S. government and military facilities and over 100 countries worldwide.

The hazard arises from unclear guidance in the service manuals. Due to this unclear guidance, service personnel performing maintenance may remove incorrect screws. If proper table supports are not in place during this maintenance activity, the table can drop unexpectedly, creating a risk of serious injury to service technicians.

GE Healthcare classified this as a Class II recall under FDA oversight. Healthcare facilities operating these systems should ensure that service personnel are aware of the hazard and follow proper maintenance procedures, including appropriate use of table supports, to prevent table drops.

The recalled product

Product
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/
Manufacturer
GE Healthcare, LLC
Category
Medical Device — CT/PET/NM Patient Tables
Hazard
  • drop-hazard
  • fall-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Rev 23 and prior
  • GTIN: N/A
  • (2) Service manual identifier 5307450-2EN
  • Rev 30 and prior
  • GTIN: Revolution Discovery CT: 00840682102490
  • Revolution Discovery CT A: 00840682125574
  • Revolution HD: N/A
  • Discovery CT750 HD: N/A
  • Rev 28 and prior
  • GTIN: Optima CT540: 00840682102551
  • Rev 2 and prior
  • GTIN: 00195278563408. (5) Service manual identifier 5366080-8EN
  • Rev 39 and prior
  • Rev 14 and prior
  • GTIN: N/A. (7) Service manual identifier 5809950-8EN
  • Rev 3 and prior
  • GTIN: Revolution Maxima: 00840682146180
  • Revolution Maxima US: 00840682147392
  • Revolution Ace: 00840682146159
  • Optima CT680 Expert: 008406821469372

Distribution

Distributed nationwide across the United States.

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