Z-0507-2025 Class II Ongoing
FDA device recall Z-0507-2025 was initiated by KCI USA, INC. on November 5, 2024 and is designated Class II. Reason for recall: Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. The recall status is ongoing. Affected quantity: 83,721 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- November 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83,721 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, 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, and WY O.U.S.(foreign) countries to: Australia, Estonia, Italy, Norway, Spain, Austria, Finland, Japan, Oman, Sweden, Bahrain, France, Jordan, Philippines, Switzerland, Brazil, Germany, Kuwait, Poland, Thailand, Canada, Greece, Malaysia, Qatar, Tunisia, Chile, Hong Kong, Malta, Romania, Turkey, China, India, Mexico, Saudi, Arabia, United Arab Emirates, Colombia, Indonesia, Morocco, Singapore, United Kingdom, Cyprus, Ireland, Netherlands, Slovenia, Czechia, Israel, New Zealand, South Africa, Vietnam, and Denmark