EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-
FDA device recall Z-2116-2014 · posted 2014-07-24 · Terminated
Recall details
- Recalling firm
- Pentax Medical Company
- Reason for recall
- Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
- Action taken
- Pentax Medical sent an Urgent Medical Device Field Safety Corrective Action dated June 12, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Pentax also posted their notification on their website. For questions regarding this action please feel free to contact Paul Silva, Recall Coordinator at Tel: 800-431-5880 ext 2064 (8:30am 5:00pm Mon-Fri, EST) Fax: 201-799-4063 Email : paul.silva@pentaxmedical.com
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FDS
- Quantity affected
- 531 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-06-12
- Date posted
- 2014-07-24
- Date terminated
- 2015-11-17
- Location
- Montvale, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FG-36UX FIBER ULTRASOUND GASTROSCOPE (K041396) | Pentax Precision Instrument Corp. | 2004-06-09 |
| EG-3830UT (K041397) | Pentax Precision Instrument Corp. | 2004-06-09 |