PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands Enterprise 1.5T, Model Number: 781145; Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Enterprise 1.5T, Model Number: 781145;
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Lot Codes / Batch Numbers
Model Number (REF): 781145, UDI-DI: N/A, All serial numbers.
Products Sold
Model Number (REF): 781145; UDI-DI: N/A; All serial numbers.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands is recalling Enterprise 1.5T, Model Number: 781145; due to 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 duri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.