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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.

FDA Recall Z-1481-2013 · Posted 2013-06-05

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2013-04-25
Date Terminated2014-02-12
Product Quantity505 units

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.

Firm Action

Philips Healthcare sent an Urgent Medical Device Correction letter dated April 26, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customer were not required to take any specific action. Customers who need further information or support concerning the affected product, they should contact their local lPhilips representative or local Philips Healthcare office. For North Americ and Canada they should contact the Customer Care Solutions Center (1-800-722-9377, option 5). For questions regarding this recall call 440-483-7600.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062298APOLLO GAMMA CAMERA SYSTEMAdac Laboratories · 2006-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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