CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report

OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled

GE OEC Medical Systems is recalling OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The, distributed in 44 states. The recall was initiated on 21 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Name: OEC 9800 GTIN code: 00840682114349 Lot/Serial Numbers / UDI codes: 82XXXX04237 (01)00840682114349(11)170600(21)82XXXX04237 8S-2249 Not Applicable-MFG date prior to UDI compliance requirement 89-1022 Not Applicable-MFG date prior to UDI compliance requirement 82-1772 Not Applicable-MFG date prior to UDI compliance requirement 82-0980 Not Applicable-MFG date prior to UDI compliance requirement 8S-1793 Not Applicable-MFG date prior to UDI compliance requirement 82-2349 Not Applicable-MFG date prior to UDI compliance requirement 82-3361 Not Applicable-MFG date prior to UDI compliance requirement 8S-1398 Not Applicable-MFG date prior to UDI compliance requirement 82-0908 Not Applicable-MFG date prior to UDI compliance requirement 82-0599 Not Applicable-MFG date prior to UDI compliance requirement 8S-0533 Not Applicable-MFG date prior to UDI compliance requirement 82-0189 Not Applicable-MFG date prior to UDI compliance requirement 8S-0186 Not Applicable-MFG date prior to UDI compliance requirement 89-2415 Not Applicable-MFG date prior to UDI compliance requirement 8S-3259 Not Applicable-MFG date prior to UDI compliance requirement 8S-3426 Not Applicable-MFG date prior to UDI compliance requirement 89-1530 Not Applicable-MFG date prior to UDI compliance requirement 82-2955 Not Applicable-MFG date prior to UDI compliance requirement 8S-0958-RC Not Applicable-MFG date prior to UDI compliance requirement 82-1154 Not Applicable-MFG date prior to UDI compliance requirement 8S-3032 Not Applicable-MFG date prior to UDI compliance requirement 8S-3145 Not Applicable-MFG date prior to UDI compliance requirement 89-1916-RC Not Applicable-MFG date prior to UDI compliance requirement 82-4134 Not Applicable-MFG date prior to UDI compliance requirement

Quantity recalled25 systems

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-0706-2025
FDA event ID: 95846
Recalling firm: GE OEC Medical Systems, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 21 Nov 2024
FDA classified: 18 Dec 2024
Reported: 25 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

21 Nov 2024	Recall initiated by company
18 Dec 2024	Classified by FDA	+27 days
25 Dec 2024	Published in enforcement report	+7 days

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

Reason for recall

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Where it was distributed

U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom

Alaska Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Maryland Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

Which lots are affected?

Product Name: OEC 9800 GTIN code: 00840682114349 Lot/Serial Numbers / UDI codes: 82XXXX04237 (01)00840682114349(11)170600(21)82XXXX04237 8S-2249 Not Applicable-MFG date prior to UDI compliance requirement 89-1022 Not Applicable-MFG date prior to UDI compliance requirement 82-1772 Not Applicable-MFG date prior to UDI compliance requirement 82-0980 Not Applicable-MFG date prior to UDI compliance requirement 8S-1793 Not Applicable-MFG date prior to UDI compliance requirement 82-2349 Not Applicable-MFG date prior to UDI compliance requirement 82-3361 Not Applicable-MFG date prior to UDI compliance requirement 8S-1398 Not Applicable-MFG date prior to UDI compliance requirement 82-0908 Not Applicable-MFG date prior to UDI compliance requirement 82-0599 Not Applicable-MFG date prior to UDI compliance requirement 8S-0533 Not Applicable-MFG date prior to UDI compliance requirement 82-0189 Not Applicable-MFG date prior to UDI compliance requirement 8S-0186 Not Applicable-MFG date prior to UDI compliance requirement 89-2415 Not Applicable-MFG date prior to UDI compliance requirement 8S-3259 Not Applicable-MFG date prior to UDI compliance requirement 8S-3426 Not Applicable-MFG date prior to UDI compliance requirement 89-1530 Not Applicable-MFG date prior to UDI compliance requirement 82-2955 Not Applicable-MFG date prior to UDI compliance requirement 8S-0958-RC Not Applicable-MFG date prior to UDI compliance requirement 82-1154 Not Applicable-MFG date prior to UDI compliance requirement 8S-3032 Not Applicable-MFG date prior to UDI compliance requirement 8S-3145 Not Applicable-MFG date prior to UDI compliance requirement 89-1916-RC Not Applicable-MFG date prior to UDI compliance requirement 82-4134 Not Applicable-MFG date prior to UDI compliance requirement

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

3 other products · FDA event 95846

This product is part of a recall event; the main page for the event is OEC 3D recalled by GE OEC Medical Systems.

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024	CLASS II	OEC 3D recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024	CLASS II	OEC Elite recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024	CLASS II	OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states

More recalls from GE OEC Medical Systems

All 47

Reported	Class	Recall	Company	Reason	Where
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
9 Aug 2023Device	CLASS II	OEC 9800 Systems with Image Intensifier recalled	GE OEC Medical Systems	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,217

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7 Oct 2026Device	CLASS II	System (RED 62 Reperfusion Catheter) recalled by Penumbra	Penumbra	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide