Z-0398-2011

SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535...

Name: Z-0398-2011 SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535...
Creator: Philips Medical Systems
Published: 2010-10-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-10-15 / Terminated

FDA source

Philips Medical Systems began a recall of SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602... on 2010-10-15. The reason FDA records is "Detector arm assembly may slide to hardware limit, potentially causing impact". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0398-2011
Status: Terminated
Initiated: 2010-10-15
Posted: 2010-11-17
Terminated: 2012-03-21
Recalling firm: Philips North America LLC
Product: SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Detector arm assembly may slide to hardware limit, potentially causing impact.
FDA root cause: Component change control
Action: Firm will notify consignees via Urgent - Medical Device Correction, dated Nov 3, 2010, via FedEx. The letter identified the affected product, described the problem, the hazard involved, how to identify affected products, actions to be taken, and actions planned by Philips. Customers are to contact their Field Safety Engineer immediately to schedule an inspection of their system. If customers suspect that the identified problem has occurred with their device, they should immediately stop using the system until Philips has confirmed it as safe to use. If customers need further information concerning this issue, they are to contact their local Philips representative.
Quantity in commerce: 24 units
Distribution: Worldwide Distribution -- USA and the Netherlands.
Product codes and lots: 3/8" SPECT, Model number 4535 600 66661, and 5/8 SPECT, Model number 4535 602 20381, all units manufactured between July 2001 to August 2003.

Product code KPS

K000908Class IISkylight Imaging SystemAdac Laboratories / cleared 2000-04-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)