Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 98960538239
FDA device recall Z-1807-2015 · posted 2015-06-15 · Terminated
Recall details
- Recalling firm
- Philips Ultrasound, Inc.
- Reason for recall
- Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent studies for other patients.
- Action taken
- PhilipsHealthcare sent an URGENT - Medical Device Correction Philips Ultrasound Q-Station, Q-STATION STRUCTURED REPORTING AND MEASUREMENTS letter, FCO 79500335, dated 2015 May 15, to all affected consignees. Philips is sending a CD with Q-Station software version 3.3.2 to consignees for a free of charge. Consignees must uninstall previous versions of Q-Station and install version 3.3.2 on your system carefully following the installation instructions that accompany the CD. It is important that consignees register their Q Station 3.3.2 installation as described in those instructions, so that Philips can confirm that they have completed this correction. Consignees were instructed to complete the enclosed Customer Reply Form to confirm that they have (1) read and understood this important Medical Device Correction and (2) have either installed Q-Station version 3.3.2 or declare that this FCO 79500335 does not apply to their institution. Consignees were asked to return the enclosed Customer Reply form to Philips Healthcare within 5 days of receipt of the replacement software. Consignees with questions can call local Philips representative or Philips Customer Service at 1-800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 125 units (30 in US and 95 international)
- Distribution
- Worldwide Distribution - US (nationwide) and Puerto Rico; internationally to Australia, Canada, Colombia, France, Germany, Great Britain, India, Italy, Mexico, Netherlands, Norway, Pakistan, Poland, R
- Date initiated
- 2015-05-15
- Date posted
- 2015-06-15
- Date terminated
- 2016-08-08
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Q-STATION (K140808) | Philips Ultrasound, Inc. | 2014-04-17 |