International safety notice
Alert 2595 (Technosurveillance) - Philips Medical Systems Ltda - DigitalDiagnost Radiology System - The patient support pedal for performing Stitching may fall and injure the foot of the product user.
Brazil / Anvisa · BRA · Jun 27, 2018
Key facts
| Title | Alert 2595 (Technosurveillance) - Philips Medical Systems Ltda - DigitalDiagnost Radiology System - The patient support pedal for performing Stitching may fall and injure the foot of the product user. |
|---|---|
| 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: DigitalDiagnost Radiology System Affected serial numbers: SN10000277, SN13000033, SN11000504, SN12000272, SN13000004 and SN13000321 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SÃO PAULO TEL 11 969109045 EMAIL LAISVIVONAPHILIPSCOM FABRICANTE DO PRODUTO PHILIPS MEDICAL SYSTEMS DMC GMBH RÖNTGENSTRABE 24 22335 HAMBURGO ALEMANHA |
| Models | SN13000033, 10216710214, SN13000004, SN11000504, SN12000272, SN10000277, SN13000321 |
| Date | Jun 27, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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