CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report

OEC Flexiview 8800 Systems with Image Intensifier recalled

GE OEC Medical Systems is recalling OEC Flexiview 8800 Systems with Image Intensifier, distributed nationwide in the US. The recall was initiated on 15 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 3228PU4, 6936PU9

Quantity recalled2

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2275-2023
FDA event ID: 92504
Recalling firm: GE OEC Medical Systems, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 15 May 2023
FDA classified: 31 Jul 2023
Reported: 9 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 May 2023	Recall initiated by company
31 Jul 2023	Classified by FDA	+77 days
9 Aug 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

OEC Flexiview 8800 Systems with 9-inch Image Intensifier

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 3228PU4, 6936PU9

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 92504

Reported	Class	Recall	Company	Reason	Where
9 Aug 2023	CLASS II	Field Upgrade Kits recalled by GE OEC Medical Systems	GE OEC Medical Systems	Other	Nationwide
9 Aug 2023	CLASS II	OEC 9900 Systems with Image Intensifier recalled	GE OEC Medical Systems	Other	Nationwide
9 Aug 2023	CLASS II	OEC 9800 Systems with Image Intensifier recalled	GE OEC Medical Systems	Other	Nationwide
9 Aug 2023	CLASS II	OEC Elite Systems with Image Intensifier recalled	GE OEC Medical Systems	Other	Nationwide

More recalls from GE OEC Medical Systems

All 47

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024Device	CLASS II	OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC Elite recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC 3D recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
9 Aug 2023Device	CLASS II	OEC Elite Systems with Image Intensifier recalled	GE OEC Medical Systems	Other	Nationwide

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