Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 1. (01)00884838068469(21) 2. (01)00884838009806(21) (1) Serial Numbers: 39011 39056 39084 39102 8989 10126 39098 39022 39079 39026 39097 39108 39082 39006 39013 39041 39081 39092 39096 39100 39010 39028 39032 39066 39086 39094 39095 39107 39001 39004 39064 39074 39007 39012 39029 39030 39034 39036 39038 39039 39040 39042 39054 39057 39058 39059 39062 39071 39075 39077 39080 39083 39088 39089 39091 39099 39105 39093 39053 39023 39008 39072 39073 39090 39104 39065 39052 39067 39085 39016 39025 39027 39060 (2) 18052 8361 8415 10015 75008 5243 8727 10172 10189 10545 18737 75002 75003 75004 75015 5547 8059 8767 8842 8883 8886 8897 8946 8981 8990 10060 18001 18710 75009 75092 75095 75099 75100 8276 10194 10512 8069 8312 8520 10006 10048 18588 75000 75001 75005 75049 75087 8289 8367 8714 8740 10539 75011 8351 8398 8782 75068 8756 75010 18505 75007 8371 8124 8467 8020 10219
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America Llc
- Reason for Recall:
- The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
Product Codes/Lot Numbers:
UDI-DI: 1. (01)00884838068469(21) 2. (01)00884838009806(21) (1) Serial Numbers: 39011 39056 39084 39102 8989 10126 39098 39022 39079 39026 39097 39108 39082 39006 39013 39041 39081 39092 39096 39100 39010 39028 39032 39066 39086 39094 39095 39107 39001 39004 39064 39074 39007 39012 39029 39030 39034 39036 39038 39039 39040 39042 39054 39057 39058 39059 39062 39071 39075 39077 39080 39083 39088 39089 39091 39099 39105 39093 39053 39023 39008 39072 39073 39090 39104 39065 39052 39067 39085 39016 39025 39027 39060 (2) 18052 8361 8415 10015 75008 5243 8727 10172 10189 10545 18737 75002 75003 75004 75015 5547 8059 8767 8842 8883 8886 8897 8946 8981 8990 10060 18001 18710 75009 75092 75095 75099 75100 8276 10194 10512 8069 8312 8520 10006 10048 18588 75000 75001 75005 75049 75087 8289 8367 8714 8740 10539 75011 8351 8398 8782 75068 8756 75010 18505 75007 8371 8124 8467 8020 10219
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1837-2024
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