FDA Device recall Z-2735-2016
BrightView X, model #882478
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of BrightView X, model #882478 by Philips Medical Systems Cleveland, citing the firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was cause….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2735-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-25 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Reason
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
Identifiers
| code_info | 11000003, 11000008, 11000030, 11000004, 11000005, 11000006, 11000007, 11000009, 11000010, 11000011, 11000012, 11000013,…11000003, 11000008, 11000030, 11000004, 11000005, 11000006, 11000007, 11000009, 11000010, 11000011, 11000012, 11000013, 11000014, 11000016, 11000017, 11000018, 11000019, 11000020, 11000022, 11000023, 11000024, 11000025, 11000026, 11000027, 11000028, 11000029, 11000031, 11000032, 11000033, 11000034, 11000035, 11000036, 11000037, 11000038, 11000039, 11000040, 11000041, 11000042, 11000043, 11000044, 11000045, 11000046, 11000047, 11000048, 11000049, 11000050, 11000051, 11000052, 11000054, 11000055, 11000056, 11000057, 11000058, 11000059, 11000060, 11000061, 11000062, 11000063, 11000064, 11000065, 11000066, 11000067, 11000068, 11000069, 11000070, 11000071, 11000072, 11000073, 11000074, 11000075, 11000076, 11000077, 11000078, 11000079, 11000080, 11000081, 11000083, 11000084, 11000085, 11000086, 11000087, 11000088, 11000089, 11000090, 11000091, 11000092, 11000093, 11000094, 11000095, 11000096, 11000097, 11000098, 11000099, 11000100, 11000101, 11000102, 11000103, 11000104, 11000105, 11000106, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2735-2016%22
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