Reported Mar 27, 2013 · Terminated
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to…
Boston Scientific CRM Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific CRM Corp · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
- Lot codes and dates
- SERIAL NUMBERS
2,094 of 2,094 codes
A002804A003105A001493A001784A001981A003024A003197A001609A001594A001733A002291A002348A002373A002195A002710A004131A001942A002278A002399A002402A001021A001136A001104A001193A001392A002093A002147A001134A001155A001063A001011A001102A001012A001004A001058A001010A001140A001093A001170A001055A001185A001144A001217A001215A001241A001367A001377A001405A001431A001380A001468A001411A001639A001688A001734A001578A001654A001799A001916A001903
- SERIAL NUMBERS
- Amount recalled
- 2090 (570 USA; 1520 OUS)
Where it was sold
Why it was recalled
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
This product could cause temporary or reversible health problems — stop using it.
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