Recall Z-0178-05 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, Inc.
HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
| Date | Nov 5, 2004 (initiated Sep 10, 2004) |
| Status | Terminated |
| Reason | Potential for device to cause burning of the skin. |
| Root cause | Other |
| Action | On 9/6/04 the firm sent a certified return receipt letter to customers advising of the issue and informing that a service representative will visit to install new software to reduce thermal output. |
| Quantity | 333 domestic units, 29 demos, 704 international units |
| Distribution | Units were distributed to medial facilities, hospitals, and veterinarians worldwide. Countries include Africa, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Domican Republic, Ecuador, France, Germany, Greece, Guam, Guatemala, Hungary, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002185 | SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc., Aug 1, 2000 |