FDA Device recall Z-2727-2026
Optima XR220amx, Mobile Digital-Ready Radiographic System
- FDA Device
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of Optima XR220amx, Mobile Digital-Ready Radiographic System by Ge Medical Systems, citing 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 bee….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2727-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-05 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
Optima XR220amx, Mobile Digital-Ready Radiographic System
Reason
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.
Identifiers
| code_info | UDI-DI: 00840682115261; System IDs: 05249MOB02.OLD, 205820DP1, 228818XR220, 229276M1, 240566P1, 301295OPTIMA2, 303788SB…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2727-2026%22
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