Z-2678-2014Class II

No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the...

Name: Z-2678-2014 No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2007-01-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-01-09 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal... on 2007-01-09. FDA classified it as Class II and gives the reason as "When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2678-2014
Classification: Class II
Status: Terminated
Initiated: 2007-01-09
Posted: 2014-09-22
Terminated: 2015-11-06
Recalling firm: Philips North America LLC
Product: No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Product code: JAX Pneumotachometer
Reason for recall: When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Philips sent a Product Safety Notification letter dated December 21, 2006 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the Product Safety Notification to all affected users and keep a copy of the notification with the Instructions for Use until further notice. Customers with questions were instructed to contact Customer Care Center at 1-800-722-9377, option 5 - Diagnostic Imaging, option 1 - CT. For questions regarding this recall call 440-483-7600.
Quantity in commerce: 61
Distribution: Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.
Product codes and lots: Model 728243 Software version 2.2.1 and 2.2.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2678-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2678-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-22

Product code JAX

K033357Class IIAcqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. / cleared 2004-01-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)