Z-1178-2017 Class II Terminated
FDA device recall Z-1178-2017 was initiated by Boston Scientific Corporation on January 12, 2017 and is designated Class II. Reason for recall: There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavio… The recall status is terminated (terminated August 9, 2018). Affected quantity: 4,500.
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2017
- Initiation Date
- January 12, 2017
- Termination Date
- August 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,500
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA ( nationwide) including PR and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY., and to the countries of :Canada, Austria, Belgium, Czech Republic, Denmark, Finland, France, French Polynesia, Guadeloupe, Monaco, New Caledonia, Reunion, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Australia, China, Egypt, Hong Kong, India, Iran, Japan, Jordan, Kuwait, Lebanon, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Thailand, Tunisia, Turkey, United Arab Emirates, Argentina, Bermuda and Brazil.