Pentax Ultrasound Gastroscopes Recalled Due to Aspiration Needle Derailment Risk
Pentax Medical is recalling 531 ultrasound gastroscopes because aspiration needles may derail from the accessory elevator, posing a risk of patient injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: The recall involves a risk-of-harm product where patient injury is possible but not explicitly reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Pentax Medical Company is recalling 531 units of specific ultrasound video and fiber gastroscopes, including models EG-3630U, EG-3830UT, EG-3870UTK, and FG-36UX. These devices are used to provide optical and sonographic visualization of and therapeutic access to the upper gastrointestinal tract. The affected units were distributed nationwide in the United States.
The recall is being issued because aspiration needles used in combination with these ultrasound gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This mechanical failure may result in patient injury if the Instruction for Use is not followed carefully by the user.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If a device is affected, users should stop using it and contact Pentax Medical Company for instructions on repair or replacement.
The recalled product
- Product
- EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
- Manufacturer
- Pentax Medical Company
- Category
- Medical Device — Endoscopy
- Affected units
- 531
Distribution
Distributed nationwide across the United States.
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