International safety notice
Alert 2694 (Technosurveillance) - Philips Medical Systems Ltda - DigitalDiagnost Radiology System - Possibility of problems in the image assembly operation Wrong baseline on the software CD.
Brazil / Anvisa · BRA · Oct 9, 2018
Key facts
| Title | Alert 2694 (Technosurveillance) - Philips Medical Systems Ltda - DigitalDiagnost Radiology System - Possibility of problems in the image assembly operation Wrong baseline on the software CD. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: DigitalDiagnost Radiology System Technical Name: Digital Radiography System ANVISA registration number: 10216710214 Risk Class: III Affected model: N/A Affected serial numbers: SN16000306 and SN16000305 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SÃO PAULO TEL 11 975763608 EMAIL LARISSAFRIASPHILIPSCOM FABRICANTE DO PRODUTO PHILIPS MEDICAL SYSTEMS DMC GMBH RÖNTGENSTRABE 24 22335 HAMBURGO ALEMANHA |
| Models | SN16000305, 10216710214, SN16000306 |
| Date | Oct 9, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1