EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide op
FDA device recall Z-1489-2012 · posted 2012-05-03 · Terminated
Recall details
- Recalling firm
- Pentax Medical Company
- Reason for recall
- Endoscope ultrasound balloon evacuation tube may become clogged with patient body fluid if users fail to properly follow instructions for pre-procedure check, operating the suction valve during procedure and pre-cleaning procedure.
- Action taken
- Pentax sent an "URGENT MEDICAL DEVICE RECALL" letter on March 14, 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. A response form was included for customers to complete and return to the firm. Contact the firm at 800-431-5880 ext. 2064 for questions regarding this notice.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 194 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-03-14
- Date posted
- 2012-05-03
- Date terminated
- 2015-07-21
- Location
- Montvale, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EG-3870UTK (K090197) | Pentax Medical Company | 2009-05-19 |