5,033 results · 42ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

B/T BLUE

FDA Adverse Event
ONCOR, INC.·Product code MAM·July 15, 1994

DAVINCI XI

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·June 7, 2025

DAVINCI XI

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 3, 2022

DAVINCI SI

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·December 12, 2024

DAVINCI XI

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·June 6, 2023

ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·November 9, 2011

DA VINCI SP

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·March 30, 2026

640G INSULIN PUMP MMT-1712K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 22, 2021

ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 17, 2013

ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857920, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

Oncor Expression Medical Linear Accelerator, Material Number: 07360717, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

Oncor Impression Medical Linear Accelerator, Material Number : 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

ONCOR Avant Garde,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5863472,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

ONCOR IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857912, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

ONCOR Expression,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 7360204 and 7360717, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 20, 2012

MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. Distributed by Siemens Healthcare, Concord, Ca. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. P

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·February 14, 2012

ONCOR Avant Garde , camera imaging system, Part Number:5863472; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS Henkestrasse, Erlangen, GERMANY The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc Radiation Oncology·Product code IYE·November 4, 2010