Recall of Automatic External Defibrillator (AED)

MODELS: 2025653, 2026109, AND 2026114. The model numbers identify different AED configurations:  MODEL 2025653 is the basic model; MODEL 2026109 is the basic model with pacing; and MODEL 2026114 is the basic model with pacing and SpO2 (oxygen saturation measured by pulse oximetry).  OPERATOR'S MANUAL PART NUMBERS: (the 3 digit number at the end identifies the language in which the manual is written. Regardless of language the manuals are identical in content.) 2026116-001, 2026116-004, 2026116-005, 2026116-008, 2026116-010, 2026116-011, 2026116-012, 2026116-013, 2026116-014, 2026116-015, 2026116-016, 2026116-019, 2026116-022, 2026116-024, 2026116-025, 2026116-026, 2026116-033, AND 2026116-044.   SERIAL NUMBERS: 3100032, 3100033, 3100035, 3100036, 3200074, 3200075, 3200094, 3200107, 3200111, 3200112, 3200113, 3200114, 3200115, 3200116, 3200117, 3200118, 3200119, 3200120, 3200121, 3200122, 3200123, 3200124, 3200125, 3200126, 3200127, 3200128, 3200129, 3200130, 3200131, 3200132, 3200133, 3200134, 3200135, 3200136, 3200137, 3200138, 3200139, 3200140, 3200141, 3200142, 3200143, 3200144, 3200145, 3200148, 3200149, 3200150, 3200151, 3200152, 3200153, 3200154, 3200155, 3200156, 3200157, 3200158, 3200159, 3200160, 3200161, 3200162, 3200163, 3200164, 3200165, 3200166, 3200167, 3200168, 3200169, 3200170, 3200171, 3200172, 3200173, 3200174, 3200175, 3200176, 3200177, 3200178, 3200179, 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Cardiovascular Devices

3

No

Worldwide distribution: USA and Australia, Brazil, Columbia, Costa Rica, Denmark, Finland, France, Germany, Italy, Korea, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Africa, Spain, and Uruguay.

Responder 2000 Defibrillator/Monitor || Models: 2025653, 2026109, and 2026114. || Intended use: The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. The 3-lead and 5-lead ECG monitoring allows for identification of interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The Responder 2000 noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. The pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.