Optima XR220amx, Mobile Digital-Ready Radiographic System
GE Medical Systems, LLC · 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 p…
Open FDA's page for this record- Cfres ID
- 221185
- Product res number
- Z-2727-2026
- Event date initiated
- 2026-06-05
- Event date posted
- 2026-07-13
- Recall status
- Open, Classified
- Res event number
- 99279
- Product code
- IZL
- Product description
- Optima XR220amx, Mobile Digital-Ready Radiographic System
- Firm FEI number
- 2126677
- Recalling firm
- GE Medical Systems, LLC
- Address 1
- 3000 N Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal code
- 53188-1615
- Additional info contact
- GE HealthCare Service 800-437-1171
- Root cause description
- Process control
- Product quantity
- 38 units
- Distribution pattern
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- Code info
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
- 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.
- Action
An URGENT MEDICAL DEVICE CORRECTION notification letter dated 6/5/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use the system by following the instructions below: Perform a check of your device prior to each patient exam to look for the following behaviors: "Column vertical movement requires increased effort. "Column has change in resistance (i.e. movement is not smooth) during vertical movement. "Column makes abnormal noises during vertical movement. If any are observed, DO NOT use the device and call GE HealthCare Service Immediately. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 10967 Digital Response Form or print, fill out manually, scan, and email to Recall.10967@gehealthcare.com.
- K numbers
- K142383, K103476
- Harmonized identifiers (openFDA)
- Device name
- System, X-Ray, Mobile
- Medical specialty description
- Radiology
- Regulation number
- 892.1720
- Device class
- 2
- K number
- K220700, K020436, K244049, K790392, K251223, K200637, K182639, K222896, K924798, K770903, K140723, K211473, K945043, K212654, K222339, K251443, K891143, K002685, K203782, K052721, K833226, K200726, K221417, K192011, K931483, K191813, K070634, K932106, K232185, K213462, K151038, K171119, K781676, K173602, K201488, K192936, K234108, K955095, K122697, K203658 +198 more
- Registration number
- 3013779985, 3005810333, 3033527770, 3012127758, 1418964, 3007836437, 3009717300, 3017375271, 3025442726, 3008496839, 3011015597, 3008044777, 3024891354, 2433615, 3023003446, 3005877899, 3013677815, 3010398867, 3001722928, 3009715136, 3014809646, 3003775006, 3015276088, 8030233, 3007065358, 3031503890, 9615439, 1418484, 3032116890, 9614430, 3018269927, 3030089787, 3018077344, 3004063527, 3016250464, 3004706313, 3003768251, 3016674851, 3008284470, 3009077524 +39 more
- FEI number
- 3013779985, 3005810333, 3033527770, 3012127758, 1418964, 3007836437, 3002495042, 3002808139, 3009717300, 1000120772, 3017375271, 3025442726, 3002143662, 3008496839, 3011015597, 3008044777, 3024891354, 2433615, 3023003446, 3005877899, 3013677815, 3010398867, 3003377038, 3001722928, 3009715136, 3014809646, 3003775006, 3015276088, 3007065358, 3031503890, 1418484, 3032116890, 3018269927, 3030089787, 3018077344, 3004063527, 3016250464, 3004706313, 3003768251, 3016674851 +39 more