FDA Medical Device Recalls (openFDA)
Philips Medical Systems Nederlands: Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System
- Recall number
- Z-0896-2019
- Recalling firm
- Philips Medical Systems Nederlands
- Product
- Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System
- Status
- Terminated
- Initiated
- 2018-12-21
- Posted
- 2019-02-22
- Terminated
- 2020-11-19
- Reason
- There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Root cause
- Unknown/Undetermined by firm
- Action
- Urgent Medical Device Correction notification letters dated December 2018 were sent to customers.
- Quantity
- 11226 total
- Distribution
- U.S. Nationwide distribution.
- Lot, serial or model codes
- All systems
- 510(k) numbers
- ["K052013"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3002807880
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
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