FDA (Devices) recall action 61479

Terumo Cardiovascular Systems Corporation recalled 11 products on 2012-07-25

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2012-07-25
Critical: 0
Units: 4,689

Why these products were recalled

Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst

Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syste

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 26 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qu
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HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a q
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0 states
HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
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0 states
HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 484 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist w
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0 states
HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 461 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by
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0 states
HighFDA (Devices)··2012-07-25
Terumo Advanced Perfusion System 1 recalled for air bubble detection malfunctions
Terumo is recalling 648 Advanced Perfusion System 1 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and oversensitivity.
Product
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfu
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0 states
HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 310 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by
Category
Distribution
0 states
HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
Terumo Cardiovascular Systems is recalling 286 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusioni
Category
Distribution
0 states
HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo Cardiovascular Systems is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qu
Category
Distribution
0 states
HighFDA (Devices)··2012-07-25
Terumo Advanced Perfusion System Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 992 Advanced Perfusion System I units worldwide due to reported malfunctions in the Air Bubble Detection System, including oversensitivity and false alarms.
Product
Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfu
Category
Distribution
0 states
HighFDA (Devices)··2012-07-25
Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 31 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist w
Category
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0 states