CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report
Brilliance CT 16 Water recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Brilliance CT 16 Water. The recall was initiated on 16 Mar 2015 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-1652-2015
- FDA event ID
- 71177
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2015
- FDA classified
- 22 May 2015
- Reported
- 3 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 16 Mar 2015 | Recall initiated by company | |
| 22 May 2015 | Classified by FDA | +67 days |
| 3 Jun 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Product as listed by the FDA
Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Where it was distributed
Distributed in China.
Questions about this recall
Is Brilliance CT 16 Water recalled?
Yes. Philips Medical Systems (Cleveland) recalled Brilliance CT 16 Water on 16 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1652-2015.
Why was it recalled?
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Which lots are affected?
System Code #, 728245, Serial #, 3500.
Where was it sold?
Distributed in China.
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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