GE OEC Surgical Navigation Systems Recalled for Unvalidated Headset Configuration
GE OEC Medical Systems is recalling 768 surgical navigation systems because the Inverted Headset Placement is not a validated configuration.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment."
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 768 units of OEC IT3000, IT2500, IT2500 Plus, IT3500, IT3500 Plus, ConneCTstat, and ConneCTstat Plus picture archiving and communications systems. These systems are used as an aid to locate anatomical structures during open or percutaneous surgical procedures, providing a reference to rigid anatomical structures visible on medical images such as CT, MRI, or X-ray.
The recall was initiated because GE Healthcare Surgery discovered that using the Inverted Headset Placement is not a validated configuration with the affected equipment. The recall covers all serial numbers of the listed models.
The affected units were distributed worldwide, including the United States (nationwide), India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark. Users should contact GE OEC Medical Systems for instructions on how to proceed with the recall.
The recalled product
- Product
- OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical…
- Manufacturer
- GE OEC Medical Systems, Inc
- Affected units
- 768
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 (1)
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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