BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD...
FDA Device Recall #Z-1982-2014 — Class II — June 23, 2014
Recall Summary
| Recall Number | Z-1982-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 23, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | 407 |
Product Description
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
Reason for Recall
Flat Panel Display (FPD) failed to remain securely locked in the deployed position.
Distribution Pattern
Worldwide Distribution - USA including the states of : AZ, CA, CO, DC, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY,OH, OK, OR, PA, TX, VT, WA,WI. Government Facilities: AZ, CA, CO, FL, HI, IA, KY, MA, MN, MO, NC, ND, NE, NV, OH, OK, SD, TX, and WV. and the countries of : Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
Lot / Code Information
BrightView XCT: product code 882482 BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454 All Codes: 6000002,6000004,6000005,6000006,6000010,6000011,6000012,6000013,6000015,6000016, 6000017,6000018,6000019, 600020, 6000021, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027,6000028,6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038,6000040,6000041, 6000042, 6000043, 6000044, 6000045, 6000046, 6000047, 6000048, 6000049, 6000050,6000051,6000052,6000053, 6000054, 6000055, 6000056, 6000057, 6000058, 6000059,6000060,6000061, 6000062, 6000063, 6000064,6000065,6000066,6000067,6000068,6000069, 6000070, 6000071, 6000072, 6000073, 6000074,6000075,6000076,6000077,6000078,6000079, 6000080, 6000081, 6000083, 6000084,6000085,6000086,6000087,6000088,6000089,6000090, 6000091, 6000092, 6000094,6000095,6000096,6000097,6000098,6000099,6000100,6000101, 6000102, 6000103, 6000104,6000105,6000106,6000107,6000108,6000109,6000110,6000111, 6000112, 6000113, 6000114,6000115,6000116,6000117,6000118,6000119,6000120,6000121, 6000122, 6000123, 6000125,6000127,6000128,6000130,6000131,6000132,6000133,6000134, 6000136, 6000139, 6000141,6000142,6000143,6000144,6000146,6000147,6000148,6000149,6000150,6000151, 6000152,6000154,6000155,6000156,6000157,6000158,6000159,6000160,6000161,6000162, 6000163,6000164,6000165,6000166,6000167,6000168,6000169,6000170,6000171,6000172, 6000173,6000174,6000175,6000176,6000177,6000178,6000179,6000180,6000181,6000182, 6000183,6000184,6000185,6000186,6000187,6000188,6000189,6000190,6000191,6000192, 6000193,6000194,6000195,6000197,6000198,6000199,6000200,6000201,6000202,6000203, 6000204,6000205,6000206,6000207,6000208,6000209,6000210,6000211,6000212,6000213, 6000214,6000215,6000216,6000217,6000218,6000219,6000220,6000221,6000222,6000223, 6000224,6000225,6000226,6000227,6000228,6000229,6000230,6000231,6000232,6000233, 6000234,6000235,6000236,6000237,6000238,6000239,6000240,6000241,6000242,6000243, 6000244,6000245,6000246,6000247,6000248,6000249,6000250,6000251,6000252,6000253, 6000254,6000255,6000257,6000258,6000259,6000260,6000261,6000262,6000263,6000264, 6000265,6000266,6000267,6000268,6000269,6000270,6000271,6000272,6000273,6000274, 6000275,6000276,6000277,6000278,6000279,6000280,6000281,6000282,6000283,6000284, 6000285,6000286,6000287,6000288,6000289,6000290,6000291,6000292,6000293,6000294, 6000295,6000296,6000297,6000298,6000299,6000300,6000301,6000302,6000303,6000304, 6000305,6000306,6000307,6000308,6000309,6000310,6000311,6000312,6000313,6000314, 6000315,6000316,6000317,6000318,6000319,6000320,6000321,6000322,6000323,6000324, 6000325,6000326,6000327,6000329,6000330,6000331,6000332,6000333,6000334,6000335, 6000336,6000337,6000338,6000339,6000340,6000341,6000342,6000343,6000344,6000345, 6000346,6000347,6000348,6000349,6000350,6000351,6000352,6000353,6000354,6000355, 6000356,6000357,6000358,6000359,6000360,6000361,6000362,6000363,6000364,6000365, 6000366,6000367,6000368,6000369,6000370,6000371,6000372,6000373,6000374,6000375, 6000376,6000377,6000378,6000379,6000380,6000381,6000382,6000383,6000384,6000385, 6000386,6000387,6000388,6000389,6000390,6000391,6000392,6000393,6000394,6000395, 6000396,6000398,6000399,6000400,6000401,6000402,6000403,6000404,6000405,6000406, 6000407,6000408,6000409,6000410,6000411,6000412,6000413,6000414,6000415,6000416, 6000417, 6000418, 6000419, 6000420, 6000421,6000422,6000423,6000424, 6000425, 6000426, 6000427, 6000428, 6340008, 6340009, 6340010, 6340011
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.