PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main
FDA device recall Z-1752-2008 · posted 2008-09-02 · Terminated
Recall details
- Recalling firm
- EKOS Corporation
- Reason for recall
- Potential for unit to burn patient.
- Action taken
- In March 2008, the firm planned to visit each consignee to install the new software version 01.05.02 and hand deliver letters, dated 02/20/2008, notifying consignees of the reason for the action. The old software version is 01.04.02. The software was upgraded because the Ultrasound Core heats very quickly and if removed from the DDC while operating it may result in burns to the patient or user. The software will turn off the Ultrasound Core automatically if removed from the DDC during operation, and will prompt to restart therapy if ultrasound is turned off during treatment. On 04/17/2008, the firm issued a new letter with the date of April 2008 informing customers of the issue. In addition the letter indicates that the corrective action, release of the new software is delayed to incorporate further changes, and that customers will be notified when the software is available for their unit. Customers are advised that the device is safe to use when operating according to the Instructions for Use. EKOS contact number 1-888-356-7435
- Root cause
- Software design
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 218 units
- Distribution
- Products were distributed nationwide to hospitals.
- Date initiated
- 2008-03-10
- Date posted
- 2008-09-02
- Date terminated
- 2011-05-13
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOWAVE INFUSION SYSTEM (K072507) | Ekos Corp. | 2007-10-04 |