Z-1046-2025Class II

Optima XR646 HD. X-Ray imaging system

Name: Z-1046-2025 Optima XR646 HD. X-Ray imaging system
Creator: GE Medical Systems, LLC
Published: 2025-01-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2025-01-28 / Open, Classified

FDA source

GE Medical Systems, LLC began a recall of Optima XR646 HD. X-Ray imaging system on 2025-01-28. FDA classified it as Class II and gives the reason as "The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1046-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-28
Posted: 2025-02-03
Recalling firm: GE Healthcare
Product: Optima XR646 HD. X-Ray imaging system.
Product code: KPR System, X-Ray, Stationary
Reason for recall: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
FDA root cause: Radiation Control for Health and Safety Act
Action: Firm sent an "IMPORTANT ELECTRONIC PRODUCT RADIATION WARNING" email/letter to its consignees. The email/letter described the product, the problem and the actions to be taken. The consignees were instructed to do the following: You can continue to use the device as intended for clinical use, by following the instructions below: 1.If you perform an exposure and observe an on-screen message that the AEC termination limit has been reached, please acknowledge the message. 2.Take any relevant actions to adjust techniques or patient positioning for the next exposure to avoid reaching the termination limit for that exposure, if appropriate. Please ensure that all potential users in your facility are made aware of this notification and the recommended actions. Please retain this document for your records. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 3149 (1697 US; 1452 OUS)
Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: GTIN: 00195278526892

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1046-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1043-2025	Class II	Ongoing	FDA Mandated	2025-02-12	2025-02-03
Z-1044-2025	Class II	Ongoing	FDA Mandated	2025-02-12	2025-02-03
Z-1045-2025	Class II	Ongoing	FDA Mandated	2025-02-12	2025-02-03
Z-1046-2025	Class II	Ongoing	FDA Mandated	2025-02-12	2025-02-03

Product code KPR

K173612Class IIOptima XR646 HDGe Hualun Medical Systems Co. , Ltd. / cleared 2017-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)