Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Reported: July 6, 2016 Initiated: June 21, 2016 #Z-2115-2016
Product Description
Ingenuity Core, model # 728326; 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 causing injury to patients, operators, by-standers and service personnel.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 1 unit
- 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? ▼
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 1 unit.
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 causing injury to patients, operators, by-standers and service personnel.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2115-2016.
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