—#153340

Product

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).

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062298, K080927
Affected lot / code info: 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,

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

Consignees received a customer information letter via certified mail, 1/31/2017. International consignees were notified by Philips Healthcare Global Market representatives. Field Service Engineers are contacting consignees to conduct appropriate corrections. Non-responders will be contacted multiple times.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

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.

Timeline

Recall initiated: 2017-01-31
Posted by FDA: 2017-03-16
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153340. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.