Z-2726-2026Class II

Optima XR200amx, Mobile Digital-Ready Radiographic System

Name: Z-2726-2026 Optima XR200amx, Mobile Digital-Ready Radiographic System
Creator: GE Medical Systems, LLC
Published: 2026-06-05
License: https://open.fda.gov/license/

GE Healthcare / initiated 2026-06-05 / Open, Classified / root cause: manufacturing process

FDA source

GE Medical Systems, LLC began a recall of Optima XR200amx, Mobile Digital-Ready Radiographic System on 2026-06-05. FDA classified it as Class II and gives the reason as "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2726-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-05
Posted: 2026-07-13
Recalling firm: GE Healthcare
Product: Optima XR200amx, Mobile Digital-Ready Radiographic System
Product code: IZL System, X-Ray, Mobile
Reason for recall: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 6/5/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use the system by following the instructions below: Perform a check of your device prior to each patient exam to look for the following behaviors: "Column vertical movement requires increased effort. "Column has change in resistance (i.e. movement is not smooth) during vertical movement. "Column makes abnormal noises during vertical movement. If any are observed, DO NOT use the device and call GE HealthCare Service Immediately. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 10967 Digital Response Form or print, fill out manually, scan, and email to [email protected].
Quantity in commerce: 4 units
Distribution: Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
Product codes and lots: UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2726-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2726-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-13
Z-2727-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-13
Z-2728-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-13

Product code IZL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)