BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Reported: March 9, 2016 Initiated: December 17, 2015 #Z-1021-2016
Product Description
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Reason for Recall
The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 117 units
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and in DC and PR and in the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Cayman Islands, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestinian, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 117 units.
Why was this product recalled? ▼
The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2016. Severity: Moderate. Recall number: Z-1021-2016.
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