Devices

Terumo APS 1

Model / Serial
Serial numbers 0020 through 0025, 0030 through 0036, 0038 through 0040, 0042, 0044, 0045, 0047 through 0102, 0106 through 0130, 0132 through 0155, 0157 through 0166, 0169 through 0216, 0218 through 0335 and 0338 through 0380.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution --- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1; Integrated (Sarns) Centrifugal System Control Unit; Catalog number 801046.
Manufacturer
Terumo Cardiovascular Systems Corp
1 Event
- Recall of Terumo APS 1

Manufacturer

Terumo Cardiovascular Systems Corp

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

56 devices with a similar name

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Terumo APS 1

Model / Serial
Serial numbers 0011 through 0395 may be affected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.
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

Terumo APS 1

Model / Serial
Serial numbers 0006 through 0066 and 0100 through 0187 may be affected. Serial numbers 0046 and 0160 have been corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.
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

Terumo APS 1

Model / Serial
Serial number range 0033 through 1308 may be affected by this problem. Serial numbers 1060 and 1148 have been corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Manufacturer
Terumo Cardiovascular Systems Corp

Terumo APS 1

Model / Serial
Serial numbers 0031 through 0324 are potentially affected by the problem. Serial numbers 0092, 0128, 0152, 0223, 0226, 0237, 0246, 0260 and 0296 have been corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
Manufacturer
Terumo Cardiovascular Systems Corp

Terumo APS 1

Model / Serial
Serial numbers 0033 through 0355 are potentially affected by the problem. Serial numbers 0033, 0041, 0049, 0052, 0105, 0115, 0117, 0119, 0122, 0145, 0151, 0159, 0160, 0161, 0162, 0170, 0174, 0218, 0226, 0242, 0257, 0262, 0277, 0279, 0290, 0299, 0300, 0305, 0306, 0331, 0334, 0339, 0343 and 0360 have been corrected.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.
Product Description
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Manufacturer
Terumo Cardiovascular Systems Corp

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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