Optima XR220amx Mobile Radiographic System Recall
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GE Medical Systems, LLC is recalling 38 units of the Optima XR220amx 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 and international. 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, Medical 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 involves the Optima XR220amx, Mobile Digital-Ready Radiographic System (UDI-DI: 00840682115261). A total of 38 units are affected, identified by the following System IDs: 05249MOB02.OLD, 205820DP1, 228818XR220, 229276M1, 240566P1, 301295OPTIMA2, 303788SBOPT1, 314251P5, 352LEEDP1, 386FLGDPXR3, 417347DPORT1, 512SAMCSB, 516632OPTIMA2, 540981ODP7, 563264OPT, 601445DP1, 615338HDP01, 661949DP2, 713441OPCDX1, 717657OPT1, 718206OPT240A, 727848SB1, 732321DP1, 757736DP3, 813302OPT1, 828213DXP1, 828286OPT1, 843847220D, 850070941, 865545DP3, 915821OPT1, 941342OP221, 972566XR220E, 985447TM4, SA1208MM05, SB2201700085WK, XR1034798WK7, XR1037005WK4. The recall number is Z-2727-2026. Distribution was worldwide, including US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, and UK.
What You Should Do
Consumers with affected systems should follow instructions provided in the firm's notification letter regarding the issue.
Why This Matters
The potential drop of the X-ray tube arm could result in patient injury during an exam.
Source
FDA recall Z-2727-2026 (Class II), initiated June 5, 2026 by GE Medical Systems, LLC.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,675 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.