International safety notice
Alert 2568 (Technosurveillance) - Philips Medical Systems Ltda - X-ray Device Possibility of detachment of the upper and lower tilt actuator with consequent rotation of the table at high speed from 0 to +90/-90 degrees.
Brazil / Anvisa · BRA · May 9, 2018
Key facts
| Title | Alert 2568 (Technosurveillance) - Philips Medical Systems Ltda - X-ray Device Possibility of detachment of the upper and lower tilt actuator with consequent rotation of the table at high speed from 0 to +90/-90 degrees. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: X-Ray Device Technical Name: Fixed X-ray Device ANVISA registration number: 10216710166 Risk Class: III Affected model: OmniDiagnost Eleva Affected serial numbers: 317 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SÃO PAULO TEL 11 975763608 21250023 EMAIL LARISSAFRIASPHILIPSCOM FABRICANTE DO PRODUTO PHILIPS MEDICAL SYSTEMS DMC GMBH RÖNTGENSTRASSE 24 D22335 HAMBURGO ALEMANHA ALEMANHA |
| Models | 10216710166 |
| Date | May 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