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Pentax of America Inc Recall 88440

Description: Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK

Pentax of America Inc Recall 88440 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2448-2021
Event ID88440
Event DescriptionColonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
Product TypeDevices
DistributionNationwide
Quantity28849 units Total
Recall ReasonUpdated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Device Classification20210922
Device Code InfoAll devices distributed by Pentax in the US between April 2014 and May 2021
Center Classification Date20210910
Recall Initiation Date20210714
Recalling FirmPentax of America Inc
Initial Notification Letter
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