Philips Bucky DIagnost X-Ray System
FDA device recall Z-0907-2007 · posted 2007-09-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.
- Action taken
- On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 1,859 units + 65 units added = 1924
- Distribution
- Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
- Date initiated
- 2007-07-23
- Date posted
- 2007-09-25
- Date terminated
- 2012-09-17
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY DIAGNOST FAMILY (K945278) | Philips Medical Systems North America, Inc. | 1994-12-14 |