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Terminated

Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D

FDA Recall Z-1964-2019 · Posted 2019-07-12

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIYN
Date Initiated2019-07-02
Date Terminated2020-10-05
Product Quantity3 devices

Reason for Recall

Potential for a transducer mis-alignment in certain transvaginal probes.

Firm Action

GE Healthcare notified customers on about 07/02/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that they could continue to use the affected probes, but prior to performing a biopsy, customers should make sure they follow the instructions for safe use in the Basic User Manual to ensure proper device alignment, specifically including the biopsy, biopsy safety and biopsy setup sections. GE Healthcare will correct all affected devices at no cost and a GE Healthcare representative will contact customers to arrange for the correction. Customers were also instructed to complete and return the Medical Device Notification Acknowledgement Response form. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Device Design

Distribution Pattern

Distribution in the US to Texas. International distribution to France, Greece and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare · 2018-11-15K173555LOGIQ E10GE Healthcare · 2017-12-20K170445LOGIQ S8GE Healthcare · 2017-04-11K160182LOGIQ S7 ExpertGE Healthcare · 2016-02-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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