Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Reported: July 6, 2016 Initiated: June 21, 2016 #Z-2111-2016
Product Description
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 3 units
- Distribution
- Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 3 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2111-2016.
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