Z-0513-2018Class II

Precedence 6 Model # 882351

Name: Z-0513-2018 Precedence 6 Model # 882351
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2017-12-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-12-15 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine... on 2017-12-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0513-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-15
Posted: 2018-02-03
Terminated: 2020-04-10
Recalling firm: Philips North America LLC
Product: 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 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.
Product code: KPS System, Tomography, Computed, Emission
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.
FDA root cause: Under Investigation by firm
Action: Philips sent an Urgent Field Safety Notice letter dated December 15, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Philips representative.
Quantity in commerce: 1387 in total
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0513-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0510-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02
Z-0511-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02
Z-0512-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02
Z-0513-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02
Z-0514-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02

Product code KPS

K041218Class IIGriffin Spect/ct Imaging SystemAdac Laboratories / cleared 2004-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)