Z-0869-2019Class II

Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System

Name: Z-0869-2019 Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
Creator: Philips Medical Systems Nederlands
Published: 2018-12-21
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2018-12-21 / Terminated

FDA source

Philips Medical Systems Nederlands began a recall of Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System on 2018-12-21. FDA classified it as Class II and gives the reason as "There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0869-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-21
Posted: 2019-02-22
Terminated: 2020-11-19
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
FDA root cause: Unknown/Undetermined by firm
Action: Urgent Medical Device Correction notification letters dated December 2018 were sent to customers.
Quantity in commerce: 11226 total
Distribution: U.S. Nationwide distribution.
Product codes and lots: All systems

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0869-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0869-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0870-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0871-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0872-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0873-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0874-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0875-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0876-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0877-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0878-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0879-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0880-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0881-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0882-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0883-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0884-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0885-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0886-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0887-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0888-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0889-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0890-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0891-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0892-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0893-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0894-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0895-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0896-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0897-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0898-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0899-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0900-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0901-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0902-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0903-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0904-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0905-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0906-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0907-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0908-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0909-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0910-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0911-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0912-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0913-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0914-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0915-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0916-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0917-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0918-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0919-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0920-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0921-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0922-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0923-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0924-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0925-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0926-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0927-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0928-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0929-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0930-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0931-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22
Z-0932-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-22

Product code LNH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)