300015094721

Organization name

Philips Medical Systems Nederland B.V.

SRN

NL-MF-000001489

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Avoid using the system with patients who are pregnant or who may possibly be pregnant. However, the risk may be outweighed by the benefit of diagnosing or treating a serious condition. It is the responsibility of the personnel operating the system to make the decision. Avoid using the system in case of existing radiation injury (operator or patient).

Primary placement in Netherlands; available across 28 countries total.

Trade name

not provided

UDI-DI code

00884838125759

Basic UDI-DI

0884838BM328SX

Reference / catalog number

300015094721

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Azurion upgrade to R4 is used to upgrade Azurion R1 and R2 to Azurion R4 software, including the installation of a biplane PC, amongst several other items. Target devices that can be upgraded are Azurion 5 and Azurion 7 ceiling or floor-mounted monoplane X-Ray systems with either a 12 inch detector or 20 inch detector.

Additional information URL

http://www.philips.com/doc_library

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z11030102STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES