PlainRecalls
FDA Devices Moderate Class II Terminated

BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

Reported: June 12, 2013 Initiated: April 25, 2013 #Z-1481-2013

Product Description

BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

Reason for Recall

Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.

Details

Units Affected
505 units
Distribution
Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV & WY. Internationally to Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, India, Indonesia, Iran, Italy, Japan, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Syria, Thailand, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Venezuela & Viet Nam.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 505 units.
Why was this product recalled?
Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 12, 2013. Severity: Moderate. Recall number: Z-1481-2013.