Z-0897-2011

Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and...

Name: Z-0897-2011 Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and...
Creator: Phillips Nuclear Medicine
Published: 2009-01-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-01-26 / Terminated

FDA source

Phillips Nuclear Medicine began a recall of Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, Model... on 2009-01-26. The reason FDA records is "A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could pose a risk to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0897-2011
Status: Terminated
Initiated: 2009-01-26
Posted: 2011-01-12
Terminated: 2011-01-13
Recalling firm: Philips North America LLC
Product: Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, Model Number: 4535 602 50851, Catalog Number: 882350, Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
Product code: INQ Table, Powered
Reason for recall: A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could pose a risk to patient.
FDA root cause: Process change control
Action: The firm, Philips Healthcare, sent an "Urgent - Field Safety Notice" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit the customers site within two months to replace the affected upper patient pallet. If you need any further information or support concerning this issue, please contact your local Philips representative at: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: and Oncology or your local Philips Healthcare office.
Quantity in commerce: 2 units
Distribution: International distribution only: Mexico and Saudi Arabia.
Product codes and lots: Serial Numbers: 3000037, 3000048

Product code INQ

K051351Class IIPrecedence Spect/ct Imaging SystemAdac Laboratories / cleared 2005-06-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)