# 00170701429600
Unscheduled inspection
Start date: 2017-02-21, end date: 2017-05-19, duration: —
Authority: Federalnaya antimonopolnaya sluzhba
Purpose of inspection: proverka informacii obnaruzhennoi antimonopolnym organom
# 642201731803
Unscheduled inspection
Start date: 2022-03-14, end date: —, duration: 5
Authority: Volzhskoe mezhregionalnoe territorialnoe upravlenie po nadzoru za yadernoi i radiacionnoi bezopasnostyu Federalnoi sluzhby po ekologicheskomu, tehnologicheskomu i atomnomu nadzoru
Purpose of inspection: Proverka soblyudeniya obyazatelnyh trebovanii v oblasti ispolzovaniya atomnoi energii pri provedenii servisnyh radiacionno-opasnyh rabot; preduprezhdenie, vyyavlenie i presechenie narushenii trebovanii zakonodatelstva RF v oblasti ispolzovaniya atomnoi energii, vypolnenie meropriyatii predusmotrennyh programmoi vneplanovoi vyezdnoi proverki v otnoshenii OOO "Filips", utverzhdennoi 04.03.2022
# 772105304508
Unscheduled inspection
Start date: 2021-01-14, end date: 2021-02-09, duration: 19
Authority: Federalnaya sluzhba po nadzoru v sfere zdravoohraneniya
Purpose of inspection: Cel : predotvraschenie
- ugrozy prichineniya vreda zhizni i zdorovyu grazhdan pri primenenii medicinskogo izdeliya «Tomograf kompyuternyi Ingenuity ST s prinadlezhnostyami», proizvodstva Philips Medical Systems (Cleveland), Inc., SSHA, registracionnoe udostoverenie № FSZ 2011/09948 ot 05.07.2011, ot 21.04.2014, 21.04.2016, 01.02.2018, 30.10.2019 (dalee – Medicinskoe izdelie).
Zadachami nastoyaschei proverki yavlyayutsya:
- vyyavlenie fakta obrascheniya falsificirovannyh, nezaregistrirovannyh, nedobrokachestvennyh medicinskih izdelii;
- vyyavlenie narusheniya trebovanii tehnicheskoi i ekspluatacionnoi dokumentacii proizvoditelya na Medicinskoe izdelie;
- proverka soblyudeniya subektami obrascheniya medicinskih izdelii pravil v sfere obrascheniya medicinskih izdelii.
Predmetom nastoyaschei proverki yavlyaetsya:
- soblyudenie obyazatelnyh trebovanii (pravil obrascheniya medicinskih izdelii) subektami obrascheniya medicinskih izdelii.
# 772005282988
Unscheduled inspection
Start date: 2020-12-16, end date: 2020-12-22, duration: 5
Authority: Federalnaya sluzhba po nadzoru v sfere zdravoohraneniya
Purpose of inspection: ugrozy prichineniya vreda zhizni i zdorovyu grazhdan pri primenenii medicinskogo izdeliya «Tomograf kompyuternyi Ingenuity ST s prinadlezhnostyami» REF 72832 SN 310347 na gentri REF 459800708861 SN 80934 na stole pacienta REF 453567023322 NS 83493 na pulte upravleniya MODEL 453567027195 SERIAL 1126 na izluchatele XRAY TUBE HOUSING ASSEMBLY model PHILIPS MRC 880 REF 9890 000 863552 SN 54016 M 144812 XRAY TUBE Model MRC 880 REF 9890 000 86371 SN 144812 proizvodstva «Filips Medikal Sistems Klivlend Ink» CSHA registracionnoe udostoverenie ot 27042016 FSZ 201109948 dalee Medicinskoe izdelieZadachami nastoyaschei proverki yavlyayutsya proverka ispolneniya programmy korrektiruyuschih meropriyatii v svyazi s nalichiem ugrozy prichineniya vreda zhizni i zdorovyu grazhdan pri primenenii Medicinskogo izdeliya proverka sootvetstviya Medicinskogo izdeliya trebovaniyam dokumentov soderzhaschihsya v registracionnom dose
# 00170701429600
Unscheduled inspection
Start date: 2017-02-21, end date: 2017-05-19, duration: —
Authority: Federalnaya antimonopolnaya sluzhba
Purpose of inspection: proverka informacii obnaruzhennoi antimonopolnym organom