Summary
The FDA issued a Class II for Optima XR200amx, Mobile Digital-Ready Radiographic System by GE Medical Systems, LLC. Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the.
Details
Source
Device Recall
External ID
Z-2726-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
Optima XR200amx, Mobile Digital-Ready Radiographic System
Lot/Code Info: UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
Quantity Affected: 4 units
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.
Distribution
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-05
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
GE Medical Systems, LLC has 143 FDA actions in our database, including 124 recalls and 19 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 143 FDA actions in our database, including 124 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2726-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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