Optima XR240amx Mobile Digital Radiographic System Recall
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GE Medical Systems, LLC is recalling 24 units of the Optima XR240amx due to potential failure of the column safety mechanism after column replacement.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
What Happened
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.
Which Products Are Affected
The recall affects the Optima XR240amx, Mobile Digital Radiographic System. 24 units are affected. UDI-DI: 00840682122351 and 00840682123686. Specific System IDs: 252847PP249, 281MSL2402, 291OPTI1, 312CCHSUPER7, 318487OPTIMA1, 360744OPT2402, 501686OPTI1, 504826XR241, 519941XR240A, 540776ODP3, 541472M4, 602344240C, 706291BEE9, 713799XR240, 770836BEE2, 813872OPT11, 813872OPT9, 843724OPT1, 843847OPT240, 870239OPT2, 905522AMX240, 973625DIG4, DF2402001002WK, SA1013MM13. Distribution is US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK. Recall number Z-2728-2026.
What You Should Do
Facilities with affected systems should verify that functional testing of the safety pawl was performed following any column replacement.
Why This Matters
The recall addresses a potential risk of the X-ray tube and collimator arm dropping, which could result in patient injury during an exam.
Source
FDA recall Z-2728-2026, Class II, initiated June 5, 2026 by GE Medical Systems, LLC.
Original source: FDA Official Notice ↗
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