Z-0948-2024Class II

Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345

Name: Z-0948-2024 Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345
Creator: Philips North America
Published: 2024-01-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-01-03 / Open, Classified / root cause: manufacturing process

FDA source

Philips North America began a recall of Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345 on 2024-01-03. 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 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0948-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-03
Posted: 2024-02-01
Recalling firm: Philips North America LLC
Product: Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Product code: LNI System, Nuclear Magnetic Resonance Spectroscopic
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: On January 4, 2024, the firm began notification of affected customers via URGENT Medical Device Correction letters. Customers were provided with precautions to take when using the device, including inspection of the QBC seal for separation. If the QBC seal is found to be loose, or becomes loose during a patient scan, customers should immediately stop use and contact their local Philips service representative. Customers should also ensure that all users of the device are aware of the issue and retain the letter with affected systems until a solution is installed. Philips will contact customers to schedule a time for a Field Service Engineer (FSE) to visit your site and replace your system's QBC Seal. Philips plans to start implementing corrections in Q3 2024. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377). Revision B of the URGENT Medical Device Correction letter was distributed to the additional US consignees on 24-Mar-2025. It was later identified that UMDC Rev B contained three MR systems with a 70cm bore (Ingenia 1.5T: 781341, Ingenia 3.0T: 781377, Ingenia Ambition X: 782109) which were incorrectly included, as the scope of this field action is MR systems with 60cm bore. The URGENT Medical Device Correction letter was updated to Rev C to remove these systems. Revision C of the UMDC was distributed to the additional US consignees on 09-Apr-2025.
Quantity in commerce: 75 US; 442 OUS
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: a. Model No. 781277; UDI-DI N/A. b. Model No. 781177; UDI-DI N/A. c. Model No. 781278; UDI-DI 00884838004139. d. Model No. 781344; UDI-DI N/A. e. Model No. 781345; UDI-DI N/A. All units affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0948-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0945-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0946-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0947-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0948-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0949-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0950-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0951-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0952-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0953-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0954-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0955-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01
Z-0956-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01

Product code LNI

K193215Class IIAchieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. / cleared 2020-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)