International safety notice
Alert 2525 (Technosurveillance) - Maquet - Volista Surgical Spotlight and Powerled/HLED Surgical Spotlight - Possibility of deviation of the light field, due to premature wear of the brake screws.
Brazil / Anvisa · BRA · Mar 19, 2018
Key facts
| Title | Alert 2525 (Technosurveillance) - Maquet - Volista Surgical Spotlight and Powerled/HLED Surgical Spotlight - Possibility of deviation of the light field, due to premature wear of the brake screws. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Volista Surgical Focus ANVISA registration number: 80259110094 Affected model: Foco Volista 600 SF Trade name: Surgical Powerled/HLED ANVISA registration number: 80259110085 Affected model: Powerled/HLED 700 SF Technical name: Surgical Focus Risk class: I Número de série afetado: 103082; 103507; 103782; 103787; 103793; 103975; 104298; 104300; 110041; 1116H000576356; 1214H000214210; 1214H000214211; 1214H000214212;1214H000214213; 1216H000580491; 1413H000110894; 1413H000110895; 1413H000110896; 1416H000587798; 1514H000222395; 2813H000135240; 2813H00013542; 2914H000253328; 2914H000253340; 2914H000253342; 2914H000253343; 2914H000253344; 2914H000253345; 2914H000253346; 2914H000253347; 3014H000253651; 3014H000253652; 3014H000253653; 3014H000253654; 3014H000253662; 3014H000253663; 3014H000253664; 3114H000255770; 3114H000255771; 3114H000255772; 3214H000259657; 3914H000275962; 3914H000275963; 3914H000275964; 3914H000275965; 3914H000275966; 3914H00027Z967; 4114H000280550; 4114H000280551; 4114H000280552; 4114H000280553; 4114H000280556; 413H000089296; 4214H000283137; 4313H000164912; 4613H000171745; 4613H000171746; 4613H000171747; 4615H000509755; 4615H000509756; 4615H000509757; 4615H000509758; 4615H000509759; 4615H000509760; 4615H000509761; 4615H000512610; 4615H000512624; 4615H000512625; 4615H000512626; 4615H000512628; 4713H000173854; 4713H000173867; 4713H000173868; 4813H000176068; 4813H000176069; 4814H000300084; 4814H000300085; 4814H000300086; 4814H000300087; 4814H000300088; 4814H000300089; 4814H000300090; 4814H000300091; 500054; 614H000200318; 614H000200319; 713H000095410; 713H000095411; 713H000095412; ON012831; ON013619; ON013620; ON015617; ON015620; ON015628; ON016647; ON016763; ON018083; ON018084; ON018849; ON019215; ON019217; ON019218; ON019219; ON019220; ON019515; ON019996; ON019997; ON019998; ON019999; ON020000; ON020001; ON020003; ON020198; ON020199; ON020275; ON020276; ON020285; ON020286; ON021262; ON021263; ON021618; ON021638; ON021666; ON022360; ON022361; ON022362; ON022363; ON022364; ON022365; ON023111; ON023113; ON023114; ON023116; ON101177; ON101228; ON102140; ON102141; ON102203; ON102204; ON102205; ON102206; ON102207; ON102208; ON102209; ON102210; ON102211; ON102212; ON102213; ON102214; ON102215; ON102216; ON102217; ON102329; ON102330; ON102331; ON102363; ON102425; ON102427; ON102428; ON102582; ON102976; ON102977; ON102978; ON102979; ON102981; ON102984; ON102985; ON102986; ON102987; ON102988; ON102989; ON102990; ON102991; ON102992; ON102993; ON103078; ON103084; ON103099; ON103100; ON103202; ON103203; ON103218; ON103230; ON103240; ON103242; ON103243 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA CNPJ 06028137000130 RUA TENENTE ALBERTO SPICCIATI 200 SÃO PAULO SP FABRICANTE MAQUET SAS PARC DE LIMÈRE AV DE LA POMME DE PIN CS10008 ARDON 45074 ORLÉANS CEDEX 2 FRANÇA TELEFONEFAX 33 238258888 EMAIL AYMERICBONNEAUGETINGECOM |
| Models | ON022364, ON016647, ON102985, 2813H00013542, ON102331, ON102990, ON020276, ON015628, ON101177, 4615H000509757, ON102976, ON019220 and 177 more |
| Date | Mar 19, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 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