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Optima recallZ-2727-2026 · GE Medical Systems, LLC · initiated Jun 5, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process control

What the company is doing

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 [email protected].

Recall details

Recall number
Z-2727-2026
Status
Open, Classified
Initiated by the company
Jun 5, 2026
Posted by the FDA
Jul 13, 2026
Recalling firm
GE Medical Systems, LLC
Quantity
38 units
Product code
IZL
FDA submissions
K142383, K103476
Distribution
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.

Product description

Optima XR220amx, Mobile Digital-Ready Radiographic System

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K142383, K103476 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99279).

Sources and updates

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