Easy Access Software releases 1.1, 5.2, 6.2 & 7.2
FDA device recall Z-1125-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.
- Action taken
- On 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 46 devices
- Distribution
- Devices were distributed to 23 hospitals and medical centers throughout the US.
- Date initiated
- 2003-06-27
- Date posted
- 2003-08-12
- Date terminated
- 2005-01-12
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WISE (II) IMAGE MANAGEMENT SYSTEM (K983447) | Sectra-Imtec AB | 1998-10-29 |