CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report
Optima XR240amx, Mobile Digital Radiographic System recalled
GE Medical Systems is recalling Optima XR240amx, Mobile Digital Radiographic System, distributed nationwide in the US. The recall was initiated on 5 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2728-2026
- FDA event ID
- 99279
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jun 2026
- FDA classified
- 13 Jul 2026
- Reported
- 22 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 5 Jun 2026 | Recall initiated by company | |
| 13 Jul 2026 | Classified by FDA | +38 days |
| 22 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Optima XR240amx, Mobile Digital Radiographic System
Where it was distributed
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99279This product is part of a recall event; the main page for the event is Optima XR200amx, Mobile Digital-Ready Radiographic System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Optima XR200amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide | |
| CLASS II | Optima XR220amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
More recalls from GE Medical Systems
All 160| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Optima XR220amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR200amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Giraffe OmniBed Field Replaceable Unit (FRU) recalled | GE Medical Systems | Other | Nationwide |
| Device | CLASS II | Allia IGS 7 Pulse angiographic X-ray system recalled | GE Medical Systems | Other | Nationwide |
| Device | CLASS II | Allia IGS 5 Pulse angiographic X-ray system recalled | GE Medical Systems | Other | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |