Precedence 6 Model # 882351 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 of
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling 1,387 units of the Precedence 6 Model # 882351 nuclear medicine imaging system due to a hazard during collimator exchange procedures. The problem occurs when the alignment of the collimator cart and detectors causes a collimator exchange to fail, potentially resulting in a collimator dropping to the floor beside the cart. The collimator may be partially supported by the cart or may fall or slide completely to the floor. The recalled units have been distributed worldwide and throughout the United States.
The recall affects Precedence 6 systems with specific serial numbers listed in the recall documentation. According to the recall record, no remedy has been specified for this issue.
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 : KP06080001 KP06090002 3000027 3000028 747866A0 KP06020006 30007020021 KP06080010 3000030 KP06090012 KP06100013 KP06110015 30007030020 30007010017 30007030021 30007060024 30007070025 30007050023 30007050022 3000029 3000036 3000002 3000040 3000031 3000032 3000033 3000038 3000035 3000034 3000039 H3000037 3000042 3000041 3000043 3000044 3000046 3000045 30007030016 3000003 3000037 6111502 KP06070007 KP06080008
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.