Philips recall
Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202…
Why was Philips recalled?
A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).
- Product
- Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202…
- Recalling firm
- Philips Medical Systems North America Inc.
- Quantity
- 489 total =227 units in US and 262 units Internationally (no Canadian consignees)
- Distribution
- Worldwide Distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV; and countries of: Australia, Austria, Belgium, Canada, Chili, Ecuador, Egypt, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea Rep, Malaysia, Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
- Recall date
- March 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)