Optima XR200amx, Mobile Digital-Ready Radiographic System
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.
- Agency
- FDA Device
- Recall date
- Jun 5, 2026
- Status
- Ongoing
- Company
- GE Medical Systems, LLC
1. What product was recalled?
Optima XR200amx, Mobile Digital-Ready Radiographic System
Optima XR200amx, Mobile Digital-Ready Radiographic System
Quantity: 4 units
Code or lot text: UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
- LOT
- 773792XR200
- LOT
- 856355OPT
- LOT
- FEB520100
- LOT
- System IDs: 419383DP3
- LOT
- UDI-DI: 00840682115278
- RECALL-NUMBER
- Z-2726-2026
Optima XR220amx, Mobile Digital-Ready Radiographic System
Optima XR220amx, Mobile Digital-Ready Radiographic System
Quantity: 38 units
Code or lot text: 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
- LOT
- 205820DP1
- LOT
- 228818XR220
- LOT
- 229276M1
- LOT
- 240566P1
- LOT
- 301295OPTIMA2
- LOT
- 303788SBOPT1
- LOT
- 314251P5
- LOT
- 352LEEDP1
- LOT
- 386FLGDPXR3
- LOT
- 417347DPORT1
- LOT
- 512SAMCSB
- LOT
- 516632OPTIMA2
- LOT
- 540981ODP7
- LOT
- 563264OPT
- LOT
- 601445DP1
- LOT
- 615338HDP01
- LOT
- 661949DP2
- LOT
- 713441OPCDX1
- LOT
- 717657OPT1
- LOT
- 718206OPT240A
- LOT
- 727848SB1
- LOT
- 732321DP1
- LOT
- 757736DP3
- LOT
- 813302OPT1
- LOT
- 828213DXP1
- LOT
- 828286OPT1
- LOT
- 843847220D
- LOT
- 850070941
- LOT
- 865545DP3
- LOT
- 915821OPT1
- LOT
- 941342OP221
- LOT
- 972566XR220E
- LOT
- 985447TM4
- LOT
- SA1208MM05
- LOT
- SB2201700085WK
- LOT
- System IDs: 05249MOB02.OLD
- LOT
- UDI-DI: 00840682115261
- LOT
- XR1034798WK7
- LOT
- XR1037005WK4
- RECALL-NUMBER
- Z-2727-2026
Optima XR240amx, Mobile Digital Radiographic System
Optima XR240amx, Mobile Digital Radiographic System
Quantity: 24 units
Code or lot text: UDI-DI: 00840682122351 and 00840682123686; 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
- LOT
- 281MSL2402
- LOT
- 291OPTI1
- LOT
- 312CCHSUPER7
- LOT
- 318487OPTIMA1
- LOT
- 360744OPT2402
- LOT
- 501686OPTI1
- LOT
- 504826XR241
- LOT
- 519941XR240A
- LOT
- 540776ODP3
- LOT
- 541472M4
- LOT
- 602344240C
- LOT
- 706291BEE9
- LOT
- 713799XR240
- LOT
- 770836BEE2
- LOT
- 813872OPT11
- LOT
- 813872OPT9
- LOT
- 843724OPT1
- LOT
- 843847OPT240
- LOT
- 870239OPT2
- LOT
- 905522AMX240
- LOT
- 973625DIG4
- LOT
- DF2402001002WK
- LOT
- SA1013MM13
- LOT
- System IDs: 252847PP249
- LOT
- UDI-DI: 00840682122351 and 00840682123686
- RECALL-NUMBER
- Z-2728-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.