International safety notice
Alert 2712 (Technosurveillance) - Philips Medical Systems Ltda - X-ray System for Computed Tomography - Possibility of the Front Cover separating from the Gantry frame, with a consequent fall.
Brazil / Anvisa · BRA · Oct 30, 2018
Key facts
| Title | Alert 2712 (Technosurveillance) - Philips Medical Systems Ltda - X-ray System for Computed Tomography - Possibility of the Front Cover separating from the Gantry frame, with a consequent fall. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: X-ray System for Computed Tomography Technical Name: Computed Tomography Equipment ANVISA registration number: 10216710191 Risk Class: III Modelo afetado: Brilliance CT 6-Slice; Brilliance CT 10-Slice; Brilliance CT 16-Slice; Brilliance CT 16-Power; Brilliance CT 40-Slice; Brilliance CT 64-Slice Affected serial numbers: See attachment "List of lots at risk" |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV MARCOS PENTEADO DE ULHOA RODRIGUES 401 SETOR PARTE 39 TAMBORÉ BARUERI SÃO PAULO TEL 11 975763608 EMAIL LARISSAFRIASPHILIPSCOM FABRICANTE DO PRODUTO PHILIPS MEDICAL SYSTEMS CLEVELAND INC 595 MINER ROAD CLEVELAND OH 44143 EUA ESTADOS UNIDOS |
| Models | 40-Slice, 16-Power, 10216710191, 16-Slice, 64-Slice, 10-Slice, 6-Slice |
| Date | Oct 30, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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