Open, Classified

SmartPath to dStream for 1.5T, Model Number: 782146;

FDA Recall Z-1782-2025 · Posted 2025-05-15

Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recall StatusOpen, Classified

Product CodeLNH

Date Initiated2025-03-24

Product Quantity3 units OUS

Reason for Recall

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.

Firm 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: [email protected].

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiPhilips Medical Systems Nederland B.V. · 2022-03-03 K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2020-04-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.