Z-0450-2015Class II

BrightView

Name: Z-0450-2015 BrightView
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-11-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-11-04 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454 on 2014-11-04. FDA classified it as Class II and gives the reason as "Software issues". 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-0450-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Posted: 2014-12-01
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Software issues
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice 88200485 is intended to inform you about: " what the issues are and under what circumstances they can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct these issues. If you need any further information or support concerning these issues, please contact your local Philips representative: For North America contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts). Philips apologizes for any inconveniences caused by this problem.
Quantity in commerce: 85
Distribution: Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
Product codes and lots: BrightView: 11000022, 11000028, 11000050, 1000067, 11000070, 11000073, 1000079, 11000080, 11000084, 11000088, and 11000109. BrightView X:4000007, 4000034, 4000045, 4000049, 4000050, 4000052, 4000055, 4000057, 4000062, 4000091, 4000110, 4000119, 4000145, 4000178, 4000186, 4000192, 4000203, 4000215, 4000221, 4000234, 4000267, 4000268, 4000273, 4000315, 4000332, 4000335, 4000337, 4000340, 4000343, 4000349, 4000351, 4000359, 4000391, 4000404, 4000436, 4000447, 4000493, 4000497, 4000500, 4000517, 4000595, 4000599, 4000605, 4000609, 4000616, 4000617, 4000622, 4000648, 4000653, and 4000675. BrightView XCT: 6000018, 6000024, 6000025, 6000029, 6000059, 6000072, 6000074, 6000096, 6000097, 6000106, 6000155, 6000170, 6000179, 6000217, 6000255, 6000259, 6000272, 6000328, 6000342, 6000357, 6000388, 6000405, 6000412, 6340011, and 11000082.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0450-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0450-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25

Product code KPS

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)