Z-2275-2023Class II

OEC Flexiview 8800 Systems with 9-inch Image Intensifier

Name: Z-2275-2023 OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Creator: GE OEC Medical Systems, Inc
Published: 2023-05-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2023-05-15 / Open, Classified / root cause: manufacturing process

FDA source

GE OEC Medical Systems, Inc began a recall of OEC Flexiview 8800 Systems with 9-inch Image Intensifier on 2023-05-15. FDA classified it as Class II and gives the reason as "Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2275-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-15
Posted: 2023-07-31
Recalling firm: GE Healthcare
Product: OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 5/15/23 correction notices were mailed to: Director/Manager of Radiology, Hospital Administrator, Head of Radiology Department, PACS Administrator, Director of IT Department, Head, Biomedical Engineering, who were asked to do the following: You can continue to use your device. When transporting the device, ensure it is always in the Anterior Posterior (AP) position, as instructed in the systems Operator Manual. Use caution when moving system to avoid a large impact force. In addition, customers were asked to complete and return the acknowledgement response form to [email protected] Customers with questions or concerns can contact the firm at 1-800-437-1171
Quantity in commerce: 2
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Czechia, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, France, Georgia, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, KOREA, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, New Caledonia, New Zealand, Nigeria, Paraguay, Peru, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Vietnam.
Product codes and lots: Serial Numbers: 3228PU4, 6936PU9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2275-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2275-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31
Z-2276-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31
Z-2277-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31
Z-2278-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31
Z-2279-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31

Product code OXO

K003837Class IIFlexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems / cleared 2001-03-12

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)