Z-1771-2025Class II
Intera 0.5T Standard, Model Number: 781101
Philips Medical Systems Nederland B.V. / initiated 2025-03-24 / Open, Classified / root cause: manufacturing process
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Intera 0.5T Standard, Model Number: 781101 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1771-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Product
- Intera 0.5T Standard, Model Number: 781101;
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- 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.
- Root cause tag
- manufacturing process
- FDA 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: [email protected].
- Quantity in commerce
- 14 units (All 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.
- Product codes and lots
- Model Number (REF): 781101; UDI-DI: N/A; All serial numbers.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1770-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1771-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1772-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1773-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1774-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1775-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1776-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1777-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1778-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1779-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1780-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1781-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1782-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1783-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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