FDA Medical Device Recalls (openFDA)
Philips North America, LLC: IntelliVue MX700 patient monitor, model no. 865241
- Recall number
- Z-2697-2020
- Recalling firm
- Philips North America, LLC
- Product
- IntelliVue MX700 patient monitor, model no. 865241
- Status
- Terminated
- Initiated
- 2020-06-30
- Posted
- not on file
- Terminated
- 2024-01-25
- Reason
- Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on.
- Root cause
- Process control
- Action
- On June 30, 2020, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were instructed to always ensure that the monitor is grounded during operation with mains power. Affected products should be removed from use until the power supply of the monitor has been replaced. Philips Customer Service will contact customers when a replacement power supply is ready for installation. Philips expects all replacements to be complete within six months. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800- 722-9377.
- Quantity
- 28
- Distribution
- Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.
- Lot, serial or model codes
- Serial numbers DE58562415 DE58562344 DE58562353
- 510(k) numbers
- ["K150310"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1218950
- Firm city
- Andover
- 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