Recall Z-2278-2016
Pentax Medical Company · initiated April 6, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Codes / lots: Model #'s FG-16V, FG-24V, FG-29V, EE-1540, EE-1580K, EG-1540, EG-1580K, EG-1840, EG-2540, EG-2940, EG-3840T, EG-3831T, EG-3870TK, EG-1870K, EG-2470K, EG-2530, EG-2730K, EG-2731, EG-2770K, EG-290KP, EG-2930K, EG-2931, EG-2931K, EG-2970K, EG-3430Z, EG-3470K, EG-3470ZK, VSB-3430K, EG-1690K, EG-2490K, EG-2790I, EG-2790K, EG27-I10, EG-2990I, EG-2990K, EG29-I10, EG-3490K and EG-3890TK.
Reason for recall
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
FDA-determined cause: Device Design
Action taken
Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.com.
Details
- Recall number
- Z-2278-2016
- Initiated
- April 6, 2016
- Posted by FDA
- July 23, 2016
- Terminated
- July 17, 2017
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Quantity
- 10,074 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Pentax Medical Company, Montvale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2275-2016 Class II | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic…Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle… | 04/06/2016Terminated |
| Z-2276-2016 Class II | Confocal GI Scope Product Usage: Intended to provide optical visualization of and…Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle… | 04/06/2016Terminated |
| Z-2277-2016 Class II | Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic…Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle… | 04/06/2016Terminated |
| Z-2279-2016 Class II | Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of…Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle… | 04/06/2016Terminated |
| Z-2280-2016 Class II | Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic…Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle… | 04/06/2016Terminated |