Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 14, 2019
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediat
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 Ent…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Ultrasound Inc recalled Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, E… - a moderate-severity action.
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, E… was recalled by Philips Ultrasound Inc in August 14, 2019. Reason: There is a potential that the image of one patient could get unexpectedly moved into another patient's folder…. Check the official notice for the remedy. Verify recall #Z-2199-2019 with the FDA Devices before acting.
The recall
Philips Ultrasound Inc issued this moderate-severity FDA Devices recall-There is a potential that the image of one patient could get unexpectedly moved into another patient's folder….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- August 14, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2199-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2199-2019) was formally reported on August 14, 2019, with the manufacturer initiating the action on April 29, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Ultrasound Inc is listed as the recalling firm, operating out of Bothell, WA. Federal records list the affected scope as 3,146 devices.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,146 devices
Related Recalls
6
3 from same agency
Product description
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Or Jan (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. When integrated with Philips EchoNavigator, the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2199-2019 |
| Date reported | August 14, 2019 |
| Date initiated | April 29, 2019 |
| Recalling firm | Philips Ultrasound Inc |
| Firm location | Bothell, WA |
| Affected scope | 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, Bangladesh, Belgium, Bolivia, Ch… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2199-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Or Jan (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. When integrated with Philips EchoNavigator, the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.. Recalled by Philips Ultrasound Inc. Units affected: 3,146 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2199-2019.
Where was the recalled product distributed? ▼
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, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Latvia, Luxembourg, Malaysia, Mayotte, Mexico, Monaco, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United Kingdom Virgin Islands, Uruguay, and Viet Nam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2199-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 14, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.