ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Num
FDA device recall Z-0643-2009 · posted 2009-01-08 · Terminated
Recall details
- Recalling firm
- Acist Medical Systems
- Reason for recall
- Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.
- Action taken
- ACIST is distributing an Urgent Medical Device Correction letter, dated November 10, 2008, to affected customers. The letter describes the issue and the scenario when the issue to occur, instructs them to discontinue use of the synchronized mode between the ACIST Angiographic Injection System model CVi and the Toshiba Infinix-i X-ray fluoroscopic system by disconnecting the interface cable immediately. The letter states that ACIST is working with Toshiba to resolve this issue. A response form is asked to be returned either by fax, e-mail or mail. If there are any questions, they should be directed to either ACIST at 952-995-9300 or local Sales Reps or Clinical Applications Specialist.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 18 cables
- Distribution
- Worldwide Distribution --- USA including states of AR, AZ, FL, and NY and countries of France, Germany, Italy, Japan, and Spain.
- Date initiated
- 2008-11-10
- Date posted
- 2009-01-08
- Date terminated
- 2011-05-07
- Location
- Eden Prairie, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS (K010390) | Acist Medical Systems, Inc. | 2001-03-09 |
| MODIFICATION TO ACIST CL 100H (K991103) | Acist Medical Systems | 2000-05-31 |