MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receivi
FDA device recall Z-0032-2012 · posted 2011-10-07 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Clinical measurements on true size printouts may be inaccurate
- Action taken
- Philips Medical notified all affected customers with a "Field Safety Notice" dated August 2011. The letter provides instructions to the customer for how to avoid the problem. Customers are informed that until the software upgrade is recieved from Philip, do not use the true-size printing feature if the system is configured for more than one DICOM printer. Customers will be instructed that they will receive a software upgrade when it is available. For questions on this recall contact Philips representative at (800) 722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 20 units
- Distribution
- Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey.
- Date initiated
- 2011-09-01
- Date posted
- 2011-10-07
- Date terminated
- 2017-03-13
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET (K072960) | Cdp, Ltd. | 2007-11-08 |