HD11XE Diagnostic Ultrasound System
FDA device recall Z-0987-2007 · posted 2007-07-03 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib
- Action taken
- On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 219 units in US and 347 units distributed internationally
- Distribution
- Worldwide.
- Date initiated
- 2007-04-25
- Date posted
- 2007-07-03
- Date terminated
- 2011-01-24
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HD11 DIAGNOSTIC ULTRASOUND SYSTEM (K043535) | Philips Ultrasound, Inc. | 2005-01-06 |