CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
OEC 9800 Systems with Image Intensifier recalled
GE OEC Medical Systems is recalling OEC 9800 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
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-2276-2023
- 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 9800 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 AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00840682114349. Serial Numbers: 89-0317, 89-0554, 8S-1293, 8S-0509, 8S-0108, 8S-1029, 8S-2836, 89-3028, 8S-1574, 89-0609-RC, 89-1308, 8S-0394, 89-0979, 8SXXXX03626, 8SXXXX03683, 8SXXXX03681, 8S-1894, 8S-0175, 8S-2988, 89-2459, 89-2101, 89-3245, 89-1623, 89-0296, 8S-0200, 8S-0748, 89-1590, 89-1713, 8S-0124, 89-0282, 8S-2580, 89-3132, 8S-3039, 89-3451, 89-0223, 89-1155, 8SXXXX03680, 8S-3278, 8S-2426, 89-2913, 8S-1167, 89-1278, 89-1854, 8S-0233-C, 8S-1926, 8SXXXX03682, 89-2167, 8S-1109, 8SXXXX03679, 8S-0410, 89-1579-N, 89-1920, 89-3102, 8S-2046-C, 89-2340, 89-0461, 89-3809, 89-3810
Where was it sold?
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.
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 92504This product is part of a recall event; the main page for the event is OEC Flexiview 8800 Systems with Image Intensifier recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | OEC Flexiview 8800 Systems with Image Intensifier recalled | GE OEC Medical Systems | Other | Nationwide | |
| CLASS II | Field Upgrade Kits recalled by GE OEC Medical Systems | GE OEC Medical Systems | Other | Nationwide | |
| CLASS II | OEC 9900 Systems with Image Intensifier recalled | GE OEC Medical Systems | Other | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 3D recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite Systems with Image Intensifier recalled | GE OEC Medical Systems | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |