Intera 1.5T
This recall is currently active, issued November 21, 2023. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- October 23, 2023
- Posted
- November 21, 2023
- Recall Number
- Z-0393-2024
- Quantity
- 102 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential component failure in the Gradient Coil could product smoke and/or fire.
Distribution
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.
Lot / Code Info
Product No. 781195 & 781295; UDI-DI: N/A; Serial No. 18510, 18516, 18529, 18550, 18564, 18567, 18578, 18583, 18592, 18657, 18660, 18667, 18678, 18701, 18709, 18711, 18714, 18725, 18727, 18769, 18773, 18776, 18787, 18812, 18820, 18854, 18856, 18857, 18870, 18873, 18878, 18884, 18889, 18890, 18905, 18906, 18907, 18913, 18917, 18920, 18923, 18931, 18935, 18947, 18948, 18950, 18965, 18973, 18986, 18998, 20402, 20403, 20404, 20409, 20426, 20441, 30004, 30030, 30037, 30038, 30064, 30079, 30081, 30082, 30131, 30187, 30190, 30199, 30200, 30206, 30213, 30218, 30219, 30223, 30234, 30235, 30236, 30238, 30255, 30256, 30265, 30266, 30267, 30268, 30272, 30274, 30277, 30278, 30279, 30280, 30281, 30284, 30285, 30288, 30293, 30296, 30297, 30298, 30303, 30311, 30312, 30315.
Root Cause
Under Investigation by firm
Action Taken
The firm mailed URGENT Medical Device Correction Notices dated 10/23/2023 to consignees to notify them of this recall event. Consignees are instructed to identify if they possess any affected devices in their inventory and to follow the provided instructions for when scan aborts occur to prevent the failure mode associated with this recall event. Consignees are to stop the scan immediately and contact Philips Service if any of the failure situations outlined in the notice occur during a scan. Consignees are asked to complete and return the provided response form to Philips no later than 30 days after receipt of the recall notice. Questions can be directed to Customer Care Solutions at 1-800-722-9377.