FDA Medical Device Recalls (openFDA)
Philips North America Llc: Achieva 1.5T Initial System
- Recall number
- Z-0391-2024
- Recalling firm
- Philips North America Llc
- Product
- Achieva 1.5T Initial System
- Status
- Open, Classified
- Initiated
- 2023-10-23
- Posted
- 2023-11-21
- Terminated
- not on file
- Reason
- Potential component failure in the Gradient Coil could product smoke and/or fire.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 2 units
- 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, serial or model codes
- Product No. 781178; UDI-DI: N/A; Serial No. 21605, 21695.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28