CLASS II Device recall · Reported 19 Nov 2014 · FDA Enforcement Report

Series OEC recalled by GE OEC Medical Systems

GE OEC Medical Systems is recalling Series OEC 9800. The recall was initiated on 3 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No: 82-0013,82-0045,82-0061,82-0071,82-0085,82-0122,82-0133,82-0190,82-0246,82-0357,82-0528,82-0533,82-0597,82-0626,82-0699,82-0702,82-0707,82-0718,82-0805,82-0818,82-0854,82-0855,82-0946,82-1040,82-1052,82-1062,82-1106,82-1133,82-1199,82-1292,82-1324,82-1348,82-1411,82-1453,82-1460,82-1526,82-1542,82-1608,82-1651,82-1658,82-1679,82-1709,82-1731,82-1773,82-1822,82-1867,82-1882,82-1905,82-1914,82-1979,82-2017,82-2018,82-2024,82-2030,82-2036,82-2049,82-2165,82-2169,82-2206,82-2225,82-2241,82-2279,82-2356,82-2388,82-2398,82-2454,82-2455,82-2459,82-2474,82-2535,82-2565,82-2603,82-2650,82-2655,82-2735,82-2751,82-2761,82-2767,82-2783,82-2851,82-2855,82-2909,82-2930,82-2945,82-2975,82-3003,82-3094,82-3096,82-3169,82-3210,82-3226,82-3232,82-3241,82-3319,82-3325,82-3377,82-3389,82-3395,82-3406,82-3424,82-3430,82-3456,82-3459,82-3500,82-3523,82-3534,82-3539,82-3569,82-3571,82-3629,82-3713,82-3748,82-3774,82-3826,82-3837,82-3851,82-3895,82-7048-MH,82-7066-MH,82-7103-MH,89-0028,89-0034,89-0037,89-0072,89-0105,89-0113,89-0135-RC,89-0184,89-0192,89-0308,89-0311,89-0316,89-0318,89-0388,89-0396,89-0427,89-0517,89-0586,89-0600,89-0623,89-0624,89-0642,89-0643,89-0743,89-0825,89-0827,89-0840,89-0843,89-0846,89-0866,89-0881,89-0894,89-0930,89-0947,89-0995,89-1023,89-1145,89-1157,89-1202,89-1204,89-1209,89-1260,89-1308,89-1327,89-1375,89-1392,89-1408,89-1411,89-1544,89-1652,89-1671,89-1698,89-1751,89-1804,89-1849,89-1868,89-1956,89-1964,89-1984,89-1986,89-2031,89-2050,89-2083,89-2085,89-2094,89-2118,89-2142,89-2170,89-2199,89-2244,89-2250,89-2336,89-2354,89-2459,89-2550,89-2555,89-2598,89-2623,89-2674,89-2682,89-2690,89-2695,89-2767,89-2777,89-2850,89-2862,89-2900,89-3031,89-3032,89-3124-N,89-3165,89-3171,89-3222,89-3252,89-3254,89-3311,89-3318,89-3346,89-3359,89-3367,89-3368,89-3419,89-3438,89-3531,8S-0014-C,8S-0026,8S-0029,8S-0058,8S-0059,8S-0070,8S-0113,8S-0162,8S-0224,8S-0232,8S-0389,8S-0467,8S-0511,8S-0529,8S-0531,8S-0549,8S-0605,8S-0755,8S-0766,8S-0782,8S-0858,8S-0876,8S-0933-C,8S-0997,8S-1000,8S-1015,8S-1147,8S-1165,8S-1166,8S-1192,8S-1427,8S-1447,8S-1509-C,8S-1565,8S-1585,8S-1897,8S-1907,8S-2008-N,8S-2053,8S-2062,8S-2092,8S-2103,8S-2107,8S-2232,8S-2234,8S-2268,8S-2310,8S-2385,8S-2408,8S-2432,8S-2445,8S-2471-C,8S-2491,8S-2530,8S-2543,8S-2550,8S-2554,8S-2564,8S-2618,8S-2650,8S-2651,8S-2671,8S-2675,8S-2695,8S-2701,8S-2734,8S-2746,8S-2770,8S-2792,8S-2798,8S-2819,8S-2835,8S-2861,8S-2862,8S-2914,8S-2922,8S-2984,8S-3004,8S-3048,8S-3055,8S-3088,8S-3143,8S-3162-H,8S-3219,8S-3272-H,8S-3289-H,8S-7102-MH,

Quantity recalled311

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-0195-2015
FDA event ID: 69474
Recalling firm: GE OEC Medical Systems, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 3 Oct 2014
FDA classified: 7 Nov 2014
Reported: 19 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

3 Oct 2014	Recall initiated by company
7 Nov 2014	Classified by FDA	+35 days
19 Nov 2014	Published in enforcement report	+12 days

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

Reason for recall

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

Product as listed by the FDA

Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it recalled?

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

Which lots are affected?

Serial No: 82-0013,82-0045,82-0061,82-0071,82-0085,82-0122,82-0133,82-0190,82-0246,82-0357,82-0528,82-0533,82-0597,82-0626,82-0699,82-0702,82-0707,82-0718,82-0805,82-0818,82-0854,82-0855,82-0946,82-1040,82-1052,82-1062,82-1106,82-1133,82-1199,82-1292,82-1324,82-1348,82-1411,82-1453,82-1460,82-1526,82-1542,82-1608,82-1651,82-1658,82-1679,82-1709,82-1731,82-1773,82-1822,82-1867,82-1882,82-1905,82-1914,82-1979,82-2017,82-2018,82-2024,82-2030,82-2036,82-2049,82-2165,82-2169,82-2206,82-2225,82-2241,82-2279,82-2356,82-2388,82-2398,82-2454,82-2455,82-2459,82-2474,82-2535,82-2565,82-2603,82-2650,82-2655,82-2735,82-2751,82-2761,82-2767,82-2783,82-2851,82-2855,82-2909,82-2930,82-2945,82-2975,82-3003,82-3094,82-3096,82-3169,82-3210,82-3226,82-3232,82-3241,82-3319,82-3325,82-3377,82-3389,82-3395,82-3406,82-3424,82-3430,82-3456,82-3459,82-3500,82-3523,82-3534,82-3539,82-3569,82-3571,82-3629,82-3713,82-3748,82-3774,82-3826,82-3837,82-3851,82-3895,82-7048-MH,82-7066-MH,82-7103-MH,89-0028,89-0034,89-0037,89-0072,89-0105,89-0113,89-0135-RC,89-0184,89-0192,89-0308,89-0311,89-0316,89-0318,89-0388,89-0396,89-0427,89-0517,89-0586,89-0600,89-0623,89-0624,89-0642,89-0643,89-0743,89-0825,89-0827,89-0840,89-0843,89-0846,89-0866,89-0881,89-0894,89-0930,89-0947,89-0995,89-1023,89-1145,89-1157,89-1202,89-1204,89-1209,89-1260,89-1308,89-1327,89-1375,89-1392,89-1408,89-1411,89-1544,89-1652,89-1671,89-1698,89-1751,89-1804,89-1849,89-1868,89-1956,89-1964,89-1984,89-1986,89-2031,89-2050,89-2083,89-2085,89-2094,89-2118,89-2142,89-2170,89-2199,89-2244,89-2250,89-2336,89-2354,89-2459,89-2550,89-2555,89-2598,89-2623,89-2674,89-2682,89-2690,89-2695,89-2767,89-2777,89-2850,89-2862,89-2900,89-3031,89-3032,89-3124-N,89-3165,89-3171,89-3222,89-3252,89-3254,89-3311,89-3318,89-3346,89-3359,89-3367,89-3368,89-3419,89-3438,89-3531,8S-0014-C,8S-0026,8S-0029,8S-0058,8S-0059,8S-0070,8S-0113,8S-0162,8S-0224,8S-0232,8S-0389,8S-0467,8S-0511,8S-0529,8S-0531,8S-0549,8S-0605,8S-0755,8S-0766,8S-0782,8S-0858,8S-0876,8S-0933-C,8S-0997,8S-1000,8S-1015,8S-1147,8S-1165,8S-1166,8S-1192,8S-1427,8S-1447,8S-1509-C,8S-1565,8S-1585,8S-1897,8S-1907,8S-2008-N,8S-2053,8S-2062,8S-2092,8S-2103,8S-2107,8S-2232,8S-2234,8S-2268,8S-2310,8S-2385,8S-2408,8S-2432,8S-2445,8S-2471-C,8S-2491,8S-2530,8S-2543,8S-2550,8S-2554,8S-2564,8S-2618,8S-2650,8S-2651,8S-2671,8S-2675,8S-2695,8S-2701,8S-2734,8S-2746,8S-2770,8S-2792,8S-2798,8S-2819,8S-2835,8S-2861,8S-2862,8S-2914,8S-2922,8S-2984,8S-3004,8S-3048,8S-3055,8S-3088,8S-3143,8S-3162-H,8S-3219,8S-3272-H,8S-3289-H,8S-7102-MH,

Where was it sold?

Worldwide Distribution.

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 69474

This product is part of a recall event; the main page for the event is FlexiView 8800 Digital Mobile Imaging System recalled.

Reported	Class	Recall	Company	Reason	Where
19 Nov 2014	CLASS II	FlexiView 8800 Digital Mobile Imaging System recalled	GE OEC Medical Systems	Other	UT
19 Nov 2014	CLASS II	OEC¿ UroView recalled by GE OEC Medical Systems	GE OEC Medical Systems	Other	UT
19 Nov 2014	CLASS II	OEC¿ MiniView recalled by GE OEC Medical Systems	GE OEC Medical Systems	Other	UT

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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All 3,883

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7 Oct 2026Device	CLASS II	Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy	Karl Storz Endoscopy	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled	ASP Global	Device Malfunction	Nationwide