Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images o
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling 1,387 Precedence 16 imaging systems (Model #882350) and Precedence 6 imaging systems (Model #882351) distributed worldwide and throughout the US. During collimator exchange procedures, misalignment between the collimator cart and detectors can cause the collimator exchange to fail, resulting in a collimator dropping to the floor beside the cart. The collimator may either be partially supported by the cart or fall completely to the floor.
The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Reason for recall: During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor. Distribution: Worldwide Distribution - US Nationwide Quantity: 1387 in total Lot/code info: Precedence 6 Model # 882351 Serial Numbers : KP05100002 KP06040012 KP05040006 KP05080007 KP05110003 KP0510008 30008 KP06110019 K06110017 6080522 30007060027 3000034 3000032 30007060029 3000006 KP06020011 KP06050013 KP06080008 KP05110004 KP06110018 30007040026 KP06070015 30007060028 3000033 30007030025 3000031 3000035 3000040 3000041 30058 3000049 3000054 3000039 3000038 3000042 3000093 3000044 3000036 3000043 3000047 KP06070048 3000074 3000059 3000055 340090 3000057 3000058 3000053 3000050 3000056 3000052 3000061 3000051 3000045 3000048 3000069 3000066 3000078 3000060 3000064 3000068 3000065 30007070030 3000071 3000063 3000067 3000062 300072 3000095 3000073 3000085 30007080011 30007040024 3000102 3000075 3000076 7021 3000092 3000098 3000087 3000077 3000082 3000080 3000081 3000088 3000079 3000083 3000084 3000089 3000091 3000096 3000097 3000100 3000086 3000090 3000099 3000094 3000104 3000101 3000103 3000105 3000106 3000037 3000708005 30006120020 30007020023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.