Achieva 1.5T Conversion
Enforcement
- Recall Number
- Z-0390-2024
- Event ID
- 93361
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2023
- Initiation Date
- October 23, 2023
- Classification Date
- November 21, 2023
- Address
- 222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States
Description
Achieva 1.5T Conversion
Potential component failure in the Gradient Coil could product smoke and/or fire.
Product No. 781283 & 781346; UDI-DI: (01)00884838009806(21)39001, (01)00884838009806(21)39027, (01)00884838009806(21)39028, (01)00884838009806(21)39030, (01)00884838009806(21)39032, (01)00884838009806(21)39039, (01)00884838009806(21)39053, (01)00884838009806(21)39059, (01)00884838009806(21)39061, (01)00884838009806(21)39062, (01)00884838009806(21)39064, (01)00884838009806(21)39065, (01)00884838009806(21)39066, (01)00884838009806(21)39067, (01)00884838009806(21)39072, (01)00884838009806(21)39073, (01)00884838009806(21)39074, (01)00884838009806(21)39075, (01)00884838009806(21)39078, (01)00884838009806(21)39080, (01)00884838009806(21)39081, (01)00884838009806(21)39082, (01)00884838009806(21)39083, (01)00884838009806(21)39084, (01)00884838009806(21)39086, (01)00884838009806(21)39088, (01)00884838009806(21)39090, (01)00884838009806(21)39091, (01)00884838009806(21)39093, (01)00884838009806(21)39094, (01)00884838009806(21)39095, (01)00884838009806(21)39097, (01)00884838009806(21)39098, (01)00884838009806(21)39100, (01)00884838009806(21)39102, (01)00884838009806(21)39105, (01)00884838009806(21)39106, (01)00884838009806(21)39107, (01)00884838068469(21)5243, (01)00884838068469(21)5547, (01)00884838068469(21)8020, (01)00884838068469(21)8276, (01)00884838068469(21)8289, (01)00884838068469(21)8361, (01)00884838068469(21)8367, (01)00884838068469(21)8371, (01)00884838068469(21)8415, (01)00884838068469(21)8714, (01)00884838068469(21)8727, (01)00884838068469(21)8740, (01)00884838068469(21)8782, (01)00884838068469(21)10189, (01)00884838068469(21)10194, (01)00884838068469(21)10219, (01)00884838068469(21)10821, (01)00884838068469(21)18505, (01)00884838068469(21)18737, (01)00884838068469(21)75000, (01)00884838068469(21)75003, (01)00884838068469(21)75004, (01)00884838068469(21)75007, (01)00884838068469(21)75008, (01)00884838068469(21)75009, (01)00884838068469(21)75015, (01)00884838068469(21)75031, (01)00884838068469(21)75068, (01)00884838068469(21)75087, (01)00884838068469(21)75092; Serial No. 39001, 39027, 39028, 39030, 39032, 39039, 39053, 39059, 39061, 39062, 39064, 39065, 39066, 39067, 39072, 39073, 39074, 39075, 39078, 39080, 39081, 39082, 39083, 39084, 39086, 39088, 39090, 39091, 39093, 39094, 39095, 39097, 39098, 39100, 39102, 39105, 39106, 39107, 5243, 5547, 8020, 8276, 8289, 8361, 8367, 8371, 8415, 8714, 8727, 8740, 8782, 10189, 10194, 10219, 10821, 18505, 18737, 75000, 75003, 75004, 75007, 75008, 75009, 75015, 75031, 75068, 75087, 75092.
Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.
68 units