Z-2143-2018 Class II Terminated
FDA device recall Z-2143-2018 was initiated by Philips Electronics North America Corporation on Apr 30, 2018 and is designated Class II. Reason for recall: Five warning statements are missing from the instructions for use. The recall status is terminated (terminated Oct 4, 2019). Affected quantity: 4,488.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 20, 2018
- Initiation Date
- Apr 30, 2018
- Termination Date
- Oct 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,488
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution -- US, 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, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and to the territories of Guam and Puerto Rico; and, countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, German, Ghana, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, UAE, and Vietnam.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2143-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026