Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8

FDA device recall Z-1590-2026 · posted 2026-03-20 · Open, Classified

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Action taken

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 2/3/26 was sent to customers. Actions to be taken by Customer / User You can continue to use your system if you DO NOT use needles with metal handles or metal hubs. A User Manual addendum is included with this letter (see Appendix A) that includes specific instructions to avoid the use of needles with metal handles or metal hubs. Please place a copy of the addendum in Appendix A with the User Manual for each Imactis CT Navigation" system in your facility. Please ensure all potential users in your facility are made aware of this safety notification and the required actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.27001@gehealthcare.com or use the QR code to submit your response electronically. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Device Design

Status

Open, Classified

Product code

JAK

Quantity affected

125 units

Distribution

Worldwide distribution - US Nationwide.

Date initiated

2026-02-03

Date posted

2026-03-20

Location

Waukesha, WI

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