CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report
No packaging recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling No packaging, distributed nationwide in the US. The recall was initiated on 9 Jan 2007 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2678-2014
- FDA event ID
- 69102
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jan 2007
- FDA classified
- 22 Sep 2014
- Reported
- 1 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2007 | Recall initiated by company | |
| 22 Sep 2014 | Classified by FDA | +2813 days |
| 1 Oct 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArkansasCaliforniaFloridaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNew JerseyNew YorkOhioPennsylvaniaRhode IslandSouth CarolinaTexasVirginiaVermont
Questions about this recall
Is No packaging recalled?
Yes. Philips Medical Systems (Cleveland) recalled No packaging on 9 Jan 2007. The recall is Class II and its status is Terminated. Recall number Z-2678-2014.
Why was it recalled?
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Which lots are affected?
Model 728243 Software version 2.2.1 and 2.2.2
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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