Z-1892-2009

BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc...

Name: Z-1892-2009 BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc...
Creator: Phillips Nuclear Medicine
Published: 2009-07-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-07-02 / Terminated / root cause: manufacturing process

FDA source

Phillips Nuclear Medicine began a recall of BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811... on 2009-07-02. The reason FDA records is "Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1892-2009
Status: Terminated
Initiated: 2009-07-02
Posted: 2009-09-16
Terminated: 2010-04-12
Recalling firm: Philips North America LLC
Product: BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm initiated its recall notification on July 6, 2009 issuing a field safety notice to its consignees via FedEx and internationally through its personnel. Responses will be tracked for effectiveness. Questions may be directed to Philips Customer Care Center at 1.800.722.9377.
Quantity in commerce: 288 units
Distribution: Worldwide
Product codes and lots: All units: 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480

Product code KPS

K062298Class IIApollo Gamma Camera SystemAdac Laboratories / cleared 2006-08-23

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)