Devices

Device Recall Terumo APS 1

  • Model / Serial
    Serial numbers 0011 through 0039, 0041 through 0308, 0310 through 0313, 0315, 0316, 0319 through 0321 and 0324 may be affected by this issue. Serial numbers 0238 and 0282 have been corrected to date.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore.
  • Product Description
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
  • Manufacturer
    Terumo Cardiovascular Systems Corp
  • 1 Event

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA

20 devices with a similar name

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Device Recall Terumo APS 1
  • Model / Serial
    Serial numbers 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00019, 00020, 00024 through 00038, 00040, 00042 through 00050, 00052 through 00063, 00065 through 00082, 00084 through 00096, 00098 through 00103, 00105 through 00123, 00125 through 00152, 00154 through 00160, 00162 through 00174, 00176 through 00197, 00199 through 00208, 00211, 00213 through 00224 and 00226.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
  • Product Description
    Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
  • Manufacturer
    Terumo Cardiovascular Systems Corp
Device Recall Terumo APS 1
  • Model / Serial
    Serial numbers 0093 and 0104 through 0114.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
  • Product Description
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763.
  • Manufacturer
    Terumo Cardiovascular Systems Corp
Device Recall Terumo APS 1
  • Model / Serial
    Serial numbers 0040 through 0044.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
  • Product Description
    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
  • Manufacturer
    Terumo Cardiovascular Systems Corp
Device Recall Terumo APS 1
  • Model / Serial
    Serial numbers 0011 through 0039 and 0041 through 0170.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
  • Product Description
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
  • Manufacturer
    Terumo Cardiovascular Systems Corp
Device Recall Terumo APS 1
  • Model / Serial
    Serial numbers 0006 through 0066.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
  • Product Description
    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
  • Manufacturer
    Terumo Cardiovascular Systems Corp
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