SONOLINE Antares Diagnostic Ultrasound System.
FDA device recall Z-0041-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
- Action taken
- On 9/5/03 the firm issued a letter dated September 2003 via overnight delivery. The letter states that a CD-Rom is included that provides a new manual that is to replace the previous manual. The new manual provides information that was previously omitted regarding the ALARA information.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 136 units
- Distribution
- The firm distributed units to 37 hospitals and medical centers nationwide. International distribution includes No military or government distribution.
- Date initiated
- 2003-09-05
- Date posted
- 2003-10-15
- Date terminated
- 2004-01-29
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM (K001400) | Siemens Medical Solutions USA, Inc. | 2000-08-01 |