Philips North America Llc: Medical Device Recall in 2023 - (Recall #: Z-0390-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Achieva 1.5T Conversion

Product Classification:

Class II

Date Initiated: October 23, 2023

Date Posted: November 29, 2023

Recall Number: Z-0390-2024

Event ID: 93361

Reason for Recall:

Potential component failure in the Gradient Coil could product smoke and/or fire.

Status: Ongoing

Product Quantity: 68 units

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated