FDA Medical Device Recalls (openFDA)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Intera 1.5T, Model Numbers: 781195 and 781295;
- Recall number
- Z-1774-2025
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Intera 1.5T, Model Numbers: 781195 and 781295;
- Status
- Open, Classified
- Initiated
- 2025-03-24
- Posted
- 2025-05-15
- Terminated
- not on file
- Reason
- The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- Root cause
- Process control
- Action
- Philips originally notified consignees on 03/24/2025 with Updated URGENT Medical Device Correction letter. It was noted that it contained incorrect information and on 04/09/2025 Philips sent an updated Updated URGENT Medical Device Correction letter. Consignees were instructed to take the following actions prior to a patient scan: 1. Inspect the QBC seal for separation between the cone cover and QBC cover. 2. If QBC seal is found detached or loose, Stop-use immediately. 3. Contact your local Philips service representative. If QBC seal becomes loose during a patient scan: 1. Immediately stop scanning and carefully remove patient from the system. 2. Contact your local Philips service representative. Consignees were also instructed to circulate this URGENT Medical Device Correction letter to all users of this device so that they are aware of the issue, retain this letter with your system(s) until a solution is installed on your system, ensure the letter is in a place likely to be seen/viewed, and complete and return the included response form to Philips promptly and no later than 30 days from receipt via email to: philips.recall@philips.com.
- Quantity
- 376 units (37 US, 339 OUS)
- Distribution
- US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.
- Lot, serial or model codes
- Model Numbers (REF): 781195, 781295; UDI-DIs: N/A; All serial numbers.
- 510(k) numbers
- ["K193215"]
- 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