Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-1021-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.

Product Classification:

Class II

Date Initiated: December 17, 2015

Date Posted: March 9, 2016

Recall Number: Z-1021-2016

Event ID: 73010

Reason for Recall:

The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause

Status: Terminated

Product Quantity: 117 units

Code Information:

Model #: 882478; Serial #'s: 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, 11000107, 11000108, 11000109, 11000110, 11000112, 11000113, 11000114, 11000115, 11000116, 11000117, 11000118, 11340001, 11340002, 11340003, 11340004, 11340005 & 11000015.

Distribution Pattern:

Worldwide Distribution-US (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and in DC and PR and in the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Cayman Islands, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestinian, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.

Voluntary or Mandated:

Voluntary: Firm initiated