PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 96728
Description: SmartPath to dStream for 3.0T, Model Number: 782145;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 96728 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1783-2025 |
| Event ID | 96728 |
| Event Description | SmartPath to dStream for 3.0T, Model Number: 782145; |
| Product Type | Devices |
| 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. |
| Quantity | 4 units OUS |
| Recall 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. |
| Device Classification | 20250521 |
| Device Code Info | Model Number (REF): 782145; UDI-DI: N/A; All serial numbers. |
| Center Classification Date | 20250515 |
| Recall Initiation Date | 20250324 |
| Recalling Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Initial Notification | Letter |
| Similar To |