Reported Jul 22, 2026 · Ongoing · Updated Sep 16, 2026
Optima XR220amx, Mobile Digital-Ready Radiographic System
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Optima XR220amx, Mobile Digital-Ready Radiographic System
- Lot codes and dates
- UDI-DI00840682115261
- System IDs
05249MOB02.OLD205820DP1228818XR220229276M1240566P1301295OPTIMA2303788SBOPT1314251P5352LEEDP1386FLGDPXR3417347DPORT1512SAMCSB516632OPTIMA2540981ODP7563264OPT601445DP1615338HDP01661949DP2713441OPCDX1717657OPT1718206OPT240A727848SB1732321DP1757736DP3813302OPT1828213DXP1828286OPT1843847220D850070941865545DP3915821OPT1941342OP221972566XR220E985447TM4SA1208MM05SB2201700085WKXR1034798WK7XR1037005WK4
- Amount recalled
- 38 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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