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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Optima XR200, XR220, and XR240amx Systems Recalled for Drop Hazard

Agency Publication Date: January 7, 2025
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Summary

GE HealthCare is recalling 454 Optima XR200amx, XR220amx, and XR240amx Mobile Digital Radiographic Systems. The recall affects units that have undergone a column replacement, as some bolts in the Column Safety mechanism may be missing. If the main support cable fails while these bolts are missing, the arm holding the X-ray tube can fall suddenly. No injuries have been reported in connection with this defect.

Risk

A missing safety bolt prevents the backup mechanism from catching the X-ray arm if the primary support cable snaps. This failure causes the heavy arm and imaging equipment to drop down the column track, posing a significant risk of impact or crushing injuries to patients or medical staff beneath the device.

What You Should Do

  1. This recall affects GE HealthCare Optima mobile X-ray systems, models XR200amx, XR220amx, and XR240amx, that have had their internal columns replaced.
  2. Check the model number and serial number on your device to determine if it is included in this recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact GE HealthCare or your authorized medical equipment distributor to schedule a technical inspection and installation of the required safety bolts.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: GE Healthcare Optima XR200amx Mobile Digital Radiographic System
Model / REF:
5555000-3
5555000-4
A0659MB
Serial Numbers (53):
260665XR220
478757OPT
512SDERLM1
904244MP5
912466AMX2
954WRMCDP2
10523MOB01
201418DIG1
210297NC200M1
229276M200
240566P1
316858AMX200P1
401OPTI3
410368WP1
443643WP1
503251XR200
512SDMCP1
518243OPT2
603356OPTIMA
609267OPT
609267OPT3
661949DP1
661949DP2
718630OPTIMAX
760379DP
801299SB1
804417OPTIMA
812237P1
813745OPT1
856355OPT
904244MP1
904244MP2
904276DP200
918477OPT1
956365OPT1
956632OPT2
956632OPT4
XR1037005WK4
405717P200
408259AP8
518583OPT1
773792XR200
7982XR0277
801230XRA
904399MP19
989907DP1
1553XR0081
316962240P1
361572XR220C
812265M200
UDI:
00840682115278

Quantity: 53 units

Product: GE Healthcare Optima XR220amx Mobile Digital Radiographic System
Model / REF:
5555000-12
5555000-5
5555000-6
A0659PB
Serial Numbers (281):
082407100532
082407160512
1557XR0205
352867XRA
478765CDP1
509962KV220
601358OPTX220
620421P3
813872OPT3
SB2201700099WK
479314220
00028MOB12
203694SB3
205820DP1
208666KDM
209334OPT1
210703M3
240566PX2
240964OPT1
248465DP3
256HHPORT2
256HHPORT3
256MHPORT1
281MSL220
281MSL2202
305KEN220A
306766DMOB2
310680PORTDR2
314251NAV7
325574OPTITBD2
330489DIGPORT
333OPTI2
333OPTI3
333OPTI4
352596OPT1
352LEEDP1
352VILDP1
386FHODP3
401OPTI1
405636P2
405636P240
405752OPT1
405752OPT2
405752OPT4
405DELCITY220
407303OPTIMAX220
408259AP6
417347DPORT1
417556P1
417556P2
UDI:
840682115261

Quantity: 281 units

Product: GE Healthcare Optima XR240amx Mobile Digital Radiographic System
Model / REF:
5555000-27
5555000-31
5555000-33
5555000-41
5555000-47
A0700DL
A1700DA
Serial Numbers (120):
228867XR240
252847PP241
281274OPT1
281338CL240
281VHVXR240
305682DIG1
305682DIG3
305KEN240B
401OPTI2
405949OPT1
408559XRDR7
413447OPT1
419251OPT
419690DP1
504842XR242
602344240A
602344MARY240
713440DP2
713440DP3
720854DF1
732222DP3
763520XR10
763520XRA6
806725OPT
865305DP1
941276XRA
970495OPTI1
973926OPT1
BOLDWPACPORT02
GLEDWPACPORT02
HMHWT240P5
LIHOPTIMA240B
OCHSNERWB240
SAMC240A
00158MOB17
DF2401800221WK
U416249MOB240
082407100689
228867XR240C
00130MOB16
5973XR0225
DEF11034
RS4025RX05
SA1058MM50
206223OPTIMA1
206248OPT2
206341OPT2402
212838OPTIMA1
219326AMX2
256HHPORT5
UDI:
840682122351

Quantity: 120 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95958
Status: Active
Manufacturer: GE Medical Systems, LLC
Sold By: Authorized GE HealthCare medical equipment distributors; Direct medical sales
Manufactured In: United States
Units Affected: 3 products (53 units; 281 units; 120 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.