Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Reported: July 29, 2015 Initiated: March 17, 2015 #Z-2205-2015
Product Description
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Reason for Recall
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 66 units
- Distribution
- Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom & Viet Nam.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 66 units.
Why was this product recalled? ▼
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2205-2015.
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