Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examinati
FDA device recall Z-0338-2009 · posted 2008-12-16 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected.
- Action taken
- Customer letters sent on Friday, Sept 5 via FedEx, 2008 to all customers. This letter will be followed up by a customer service visit. Package delivery will be tracked, as well as Reply Verification tracking forms.For further information, please contact firm at 508-652-5594.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 357 units
- Distribution
- World-wide distribution including USA and countries of Europe, Middle East, Africa, and Japan.
- Date initiated
- 2008-09-05
- Date posted
- 2008-12-16
- Date terminated
- 2009-05-18
- Location
- Fremont, CA
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