Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC
FDA device recall Z-2199-2019 · posted 2019-08-06 · Terminated
Recall details
- Recalling firm
- Philips Ultrasound Inc
- Reason for recall
- There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of the device.
- Action taken
- The recalling firm issued letters dated 4/26/2019 on 4/29/2019 via certified mail with delivery confirmation. The letter identified the affected product, problem and actions to be taken.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 3,146 devices
- Distribution
- Worldwide Distribution - US Nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain
- Date initiated
- 2019-04-29
- Date posted
- 2019-08-06
- Date terminated
- 2022-08-04
- Location
- Bothell, WA
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