Food, drugs, devices › Philips Medical Systems (Cleveland) Inc
Device recall: Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intend
Philips Medical Systems (Cleveland) Inc (Cleveland, OH) initiated this device recall on 27 Dec 2005; FDA lists 1 product record under event 69123, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 100% of the 3 device enforcement events initiated in 2005 carry the same class.
Status: Terminated, terminated 6 Nov 2015. Initiation: voluntary: firm initiated. Philips Medical Systems (Cleveland) Inc has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Medical Systems (Cleveland) Inc, Cleveland, OH.
Reason for recall
"The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle."
Distribution
"Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2709-2014 | Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs. | 364 | Class II | Terminated | 1 Oct 2014 |
Context
Other enforcement events for Philips Medical Systems (Cleveland) Inc
All 129 events for Philips Medical Systems (Cleveland) Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Nov 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.