Z-0249-2012

SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc...

Name: Z-0249-2012 SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc...
Creator: Philips Medical Systems
Published: 2011-09-27
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-09-27 / Terminated / root cause: design

FDA source

Philips Medical Systems began a recall of SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight... on 2011-09-27. The reason FDA records is "A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0249-2012
Status: Terminated
Initiated: 2011-09-27
Posted: 2011-11-19
Terminated: 2012-12-21
Recalling firm: Philips North America LLC
Product: SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product 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: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Root cause tag: design
FDA root cause: Device Design
Action: Philips Medical Systems sent a "Customer Information" letter dated September 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter lists additional precautions the customers should use while operating the device. Philips will notify customers for replacing the affected product through an Action for Performance-Proactive Field Change Order to resolve the issue. Contact Philips Customer Care Solutions at 1-800-722-9377, option 5, for questions concerning this notice.
Quantity in commerce: 658 - all units in recall
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico.
Product codes and lots: Model numbers: 2160-3000A 4535-600-66661

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)