FDAFDA recall Z-2727-2026 · Jul 22, 2026
GE Medical Systems, LLC: Optima XR220amx recall
Recall found
Product
Optima XR220amx, Mobile Digital-Ready Radiographic System
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00840682115261; 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
- Quantity
- 38 units
- Distribution
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-05
Source: openFDA enforcement record Z-2727-2026 · search recall number Z-2727-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.