GE OEC InstaTrak 3500 Plus Surgical Navigation System Software Recall
GE OEC Medical Systems recalled 86 InstaTrak 3500 Plus surgical navigation systems due to software-related issues. The recall was initiated in 2006 but recently classified by the FDA due to administrative delays.
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: "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System…"
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 86 units of the InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. The recall was originally initiated on October 11, 2006, due to software-related issues affecting the surgical Navigation and Visualization Application. The FDA notes that this is not a new recall, but rather a recent administrative classification of an action already taken by the firm.
The affected systems are used as an aid to locate anatomical structures during open or percutaneous surgical procedures. They are indicated for use in medical conditions that may benefit from stereotactic surgical technique, providing a reference to rigid anatomical structures such as the sinus, skull, long bone, or vertebra visible on CT, MR, or X-ray images. The distribution pattern for these units is listed as worldwide, including nationwide distribution in the United States.
The source text does not specify the exact nature of the software defect, the specific corrective actions taken by the firm, or instructions for consumers or healthcare providers on how to proceed. No illnesses, injuries, or deaths are reported in the provided text.
The recalled product
- Product
- InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical…
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 86
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)
- IT35050P
- IT35071
- IT35129
- IT35133
- IT35134
- IT35139
- IT35140
- IT35143P-RC
- IT35144P
- IT35145P-RC
- IT35146
- IT35147P-RC
- IT35148
- IT35150
- IT35153P
- IT35156
- IT35161
- IT35162P-RC
- IT35164
- IT35169P-RC
Distribution
Distributed nationwide across the United States.
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