Z-2737-2016Class II

BrightView XCT Upgrade Model 882454

Name: Z-2737-2016 BrightView XCT Upgrade Model 882454
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-05-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-05-25 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of BrightView XCT Upgrade Model 882454 on 2016-05-25. FDA classified it as Class II and gives the reason as "The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2737-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-25
Posted: 2016-09-03
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: BrightView XCT Upgrade Model 882454
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
Root cause tag: software
FDA root cause: Software design
Action: The firm is informing the consignee of this issue through Customer Information Letter.
Quantity in commerce: 3 units
Distribution: Worldwide distribution. US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Product codes and lots: 11000021, 11000082, 11000111

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2737-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2735-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-03
Z-2736-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-03
Z-2737-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-03

Product code KPS

K080927Class IIBrightview Vct Imaging SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2008-04-11

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)