510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1578-2024Class II

Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System

Philips North America LLC / initiated 2024-03-12 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Philips North America Llc began a recall of Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System on . FDA classified it as Class II and gives the reason as "Patient support table floor plate may be incorrectly installed". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1578-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Philips North America LLC
Product
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall
Patient support table floor plate may be incorrectly installed.
Root cause tag
manufacturing process
FDA root cause
Process design
Action
Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to [email protected].
Quantity in commerce
20 units
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., 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, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.
Product codes and lots
Model No. 781173; UDI-DI n/a; Serial No. 13010, 13013, 13028, 13017, 13033, 13058, 13061, 13071, 13056, 13074, 13057, 13044, 13060, 13027, 13067, 13049, 13048, 13043, 13008, 13012.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1578-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1550-2024Class IIOngoingVoluntary: Firm initiated
Z-1551-2024Class IIOngoingVoluntary: Firm initiated
Z-1552-2024Class IIOngoingVoluntary: Firm initiated
Z-1553-2024Class IIOngoingVoluntary: Firm initiated
Z-1554-2024Class IIOngoingVoluntary: Firm initiated
Z-1555-2024Class IIOngoingVoluntary: Firm initiated
Z-1556-2024Class IIOngoingVoluntary: Firm initiated
Z-1557-2024Class IIOngoingVoluntary: Firm initiated
Z-1558-2024Class IIOngoingVoluntary: Firm initiated
Z-1559-2024Class IIOngoingVoluntary: Firm initiated
Z-1560-2024Class IIOngoingVoluntary: Firm initiated
Z-1561-2024Class IIOngoingVoluntary: Firm initiated
Z-1562-2024Class IIOngoingVoluntary: Firm initiated
Z-1563-2024Class IIOngoingVoluntary: Firm initiated
Z-1564-2024Class IIOngoingVoluntary: Firm initiated
Z-1565-2024Class IIOngoingVoluntary: Firm initiated
Z-1566-2024Class IIOngoingVoluntary: Firm initiated
Z-1567-2024Class IIOngoingVoluntary: Firm initiated
Z-1568-2024Class IIOngoingVoluntary: Firm initiated
Z-1569-2024Class IIOngoingVoluntary: Firm initiated
Z-1570-2024Class IIOngoingVoluntary: Firm initiated
Z-1571-2024Class IIOngoingVoluntary: Firm initiated
Z-1572-2024Class IIOngoingVoluntary: Firm initiated
Z-1573-2024Class IIOngoingVoluntary: Firm initiated
Z-1574-2024Class IIOngoingVoluntary: Firm initiated
Z-1575-2024Class IIOngoingVoluntary: Firm initiated
Z-1576-2024Class IIOngoingVoluntary: Firm initiated
Z-1577-2024Class IIOngoingVoluntary: Firm initiated
Z-1578-2024Class IIOngoingVoluntary: Firm initiated
Z-1579-2024Class IIOngoingVoluntary: Firm initiated
Z-1580-2024Class IIOngoingVoluntary: Firm initiated
Z-1581-2024Class IIOngoingVoluntary: Firm initiated
Z-1582-2024Class IIOngoingVoluntary: Firm initiated
Z-1583-2024Class IIOngoingVoluntary: Firm initiated
Z-1584-2024Class IIOngoingVoluntary: Firm initiated
Z-1585-2024Class IIOngoingVoluntary: Firm initiated
Z-1586-2024Class IIOngoingVoluntary: Firm initiated
Z-1587-2024Class IIOngoingVoluntary: Firm initiated
Z-1588-2024Class IIOngoingVoluntary: Firm initiated
Z-1589-2024Class IIOngoingVoluntary: Firm initiated
Z-1590-2024Class IIOngoingVoluntary: Firm initiated