Z-2306-2021 Class II
FDA device recall Z-2306-2021 was initiated by Philips Ultrasound Inc on July 22, 2021 and is designated Class II. Reason for recall: Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system,… Affected quantity: 8935.
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- July 22, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8935
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of FL, UT, CA, CO, WA, MS, NC, NV, GA, LA, VA, SC, NE, TN, HI, OR, ID, MI, OH, IN, IL, OK, TX, PA, NJ, CT, NY, DE, SD, WI, VT, MN, KS, MO, KY, MA, NH, IA, MT, NM, ME, AZ, AR, AL, WY, ND, AK, MD, RI, WV, DC, VI and the countries of Argentina, Australia, Bahrain, Peru, Serbia, Bolivia, Moldova, Albania, Ukraine, Uruguay, Belarus, Hungary, Greece, Honduras, Montenegro, Senegal, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Dominican Republic, Germany, Ecuador, Estonia, Finland, Taiwan, Georgia, United Kingdom, Guatemala, Hong Kong, Indonesia, Iran, Israel, Yemen, Jordan, Korea, Republic of, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Morocco, Mauritius, Nicaragua, New Zealand, Norway, Oman, United Arab Emirates, Austria, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Thailand, Czech Republic, Tunisia, Uzbekistan, South Africa, Sweden, Switzerland, Netherlands, France, Monaco, Martinique, New Caledonia, Italy, China, India, Denmark, Singapore, Belgium, Spain, Mexico, Viet Nam, Philippines, Malaysia, Japan, Bangladesh, Ireland, Luxembourg, Andorra, Nepal, Myanmar, Pakistan, Brunei Darussalam, French Guiana, Sri Lanka, Kazakhstan, Egypt, Turkey, Kuwait, Romania, Slovakia, Croatia, Slovenia, Bosnia and Herzegovina.