Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2017 - (Recall #: Z-1481-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

Product Classification:

Class II

Date Initiated: January 31, 2017

Date Posted: March 22, 2017

Recall Number: Z-1481-2017

Event ID: 76483

Reason for Recall:

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

Status: Terminated

Product Quantity: 1218 total

Code Information:

11000100, 11000019, 11000034, 11000020, 11000112, 11000086, 11000045, 11000092, 11000037, 11000038, 11000106, 11000059, 11000064, 11000039, 11000087, 11000004, 11000058, 11000030, 11340005, 11000113, 11000117, 11000011, 11000118, 11000074, 11000075, 11000036, 11000104, 11000103, 11000071, 11340002, 11000089, 11000012, 11000041, 11000042, 11000043, 11000049, 11000014, 11000099, 11000022, 11000031, 11000005, 11000028, 11000073, 11000040, 11000077, 11000008, 11000048, 11000093, 11000096, 11000097, 11000069, 11000079, 11000080, 11000024, 11000076, 11000085, 11000108, 11000109, 11000115, 11000056, 11000029, 11340003, 11000044, 11000107, 11000090, 11000017, 11000110, 11000009, 11000035, 11000081, 11000062, 11000013, 11000015, 11000063, 11000083, 11000091, 11000098, 11000054, 11340004, 11000102, 11000061, 11000095, 11000023, 11000094, 11000060, 11000055, 11000070, 11000084, 11000088, 11000068, 11000052, 11000057, 11000050, 11000067, 11000007, 11000010, 11000027, 11000032, 11340001, 11000026, 11000114, 11000078, 11000051, 11000046, 11000003, 11000018, 11000066, 11000047, 11000101, 11000065, 11000072, 11000116, 11000016, 11000105, 11000025, 11000006, 11000033,

Distribution Pattern:

Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, & VIETNAM.

Voluntary or Mandated:

Voluntary: Firm initiated