Device Recall Philips

  • Model / Serial
    Software Revision: B.02.07
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Philips Telemonitoring System Software (M3811B) used with || Philips Telemonitoring System (M3810B) || Revision: B.02.07 || Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

229 devices with a similar name

Learn more about the data here

  • Model / Serial
    SN120001-SN120003, SN130001-SN130023, SN140001-SN140022, SN140024, SN140027, SN140030-SN140031, SN140033-SN140046, SN140048, SN140050-SN140068, SN150001-SN150004, SN150006, SN150008-SN150011, SN160001, SN160002
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : Ca and Oh., and to the countries of: Australia, Libya, China, Mayotte, Mexico, France, United Kingdom, Germany, Ecuador, Australia, Spain, Switzerland, Macedonia, Uzbekistan, Kuwait, Malaysia, Netherlands, Argentina, Chile, Colombia, Egypt, United Arab Emirates, Saudi Arabia, Hungary, Peru, Poland, Indonesia, Burkina Faso, Kazakhstan, Turkey and Slovenia.
  • Product Description
    Philips DuraDiagnost X-ray systems: || DuraDiagnost (R1.0, Product Number 712210) || DuraDiagnost (R2.0, Product Number 712211) || DuraDiagnost (R3.0, Product Number 712211)
  • Manufacturer
  • Model / Serial
    This action affects certain customers who were shipped an affected Philips Intellivue Information Center unit between June 9, 2008 and May 31, 2009. Affected products have a PC serial number range between 2UA8300XYZ and 2UA84510QW. However, only a subset of these products are affected.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) OUS: CANADA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL CHILE CHINA COLOMBIA CZECH REPUBLIC FINLAND FRANCE GERMANY GREECE INDIA INDONESIA IRELAND ITALY JAPAN KENYA KOREA, REPUBLIC OF NETHERLANDS PHILIPPINES POLAND SPAIN SWEDEN SWITZERLAND THAILAND TURKEY UNITED KINGDOM
  • Product Description
    M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. || The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
  • Manufacturer
  • Model / Serial
    7220063, 722064, 22065, 722066, 722078, 722079
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution.
  • Product Description
    Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 || The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP) Non-vascular interventions such as drainages, biopsies and vertebroplastics procedures The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
  • Manufacturer
  • Model / Serial
    9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    412 units affected.
  • Product Description
    Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
  • Manufacturer
  • Model / Serial
    Code 728306, SN# 100776, UDI: (01)00884838059474(21)100776; 100778, UDI: (01)00884838059474(21)100778; 100779, UDI: (01)00884838059474(21)100779; 100780, UDI: (01)00884838059474(21)100780; 100781, UDI: (01)00884838059474(21)100781; 100782, UDI: (01)00884838059474(21)100782; 100783, UDI: (01)00884838059474(21)100783; 100784, UDI: (01)00884838059474(21)100784; 100785, UDI: (01)00884838059474(21)100785; 100787, UDI: (01)00884838059474(21)100787; 100790, UDI: (01)00884838059474(21)100790; 100791, UDI: (01)00884838059474(21)100791; and  100794, UDI: (01)00884838059474(21)1007.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
  • Product Description
    Brilliance iCT || Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
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