Food, drugs, devices › Philips Medical Systems (Cleveland) Inc
Device recall: Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
FDA enforcement event 74511 is a device recall by Philips Medical Systems (Cleveland) Inc of Cleveland, OH, initiated 21 Jun 2016 and classified Class II, with 5 product records.
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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 2 Jul 2018. 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
"Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel."
Distribution
"Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2111-2016 | Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body. | 3 units | Class II | Terminated | 6 Jul 2016 |
| Z-2112-2016 | Brilliance iCT model #728306; Intended to produce cross- sectional images of the body. | 1 unit | Class II | Terminated | 6 Jul 2016 |
| Z-2113-2016 | Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body. | 10 units | Class II | Terminated | 6 Jul 2016 |
| Z-2114-2016 | Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body. | 14 units | Class II | Terminated | 6 Jul 2016 |
| Z-2115-2016 | Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body. | 1 unit | Class II | Terminated | 6 Jul 2016 |
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: "Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel."
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: "Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Jul 2018. "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.