Reported Feb 14, 2018 · Terminated
Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Precedence 16 Model # 882350
- Product UsagePrecedence (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 the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals
- Lot codes and dates
- Precedence 6 Model # 882351
- Serial Numbers
106 of 106 codes
KP05100002KP06040012KP05040006KP05080007KP05110003KP051000830008KP06110019K0611001760805223000706002730000343000032300070600293000006KP06020011KP06050013KP06080008KP05110004KP0611001830007040026KP06070015300070600283000033300070300253000031300003530000403000041300583000049300005430000393000038300004230000933000044300003630000433000047KP06070048300007430000593000055340090300005730000583000053300005030000563000052300006130000513000045300004830000693000066300007830000603000064
- Amount recalled
- 1387 in total
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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