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Invivo
Philips Ds North America LLC · Model 9896-031-10735 · UDI-DI 00884838115255
MOS
Prescription
10
510(k) clearances
136
Adverse events
38
Recalls
78
Facilities
Description
BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assemblies; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 LBS C-C Grid Immobilization Plates Sterilized; 3 LBS C-C Pillar Immobilization Plates Sterilized; 2 Biopsy Fiducial Markers; MRI Needle Sleeve 16G; Fiducial Marker Block; 2 Needle Block Holder.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| 2024-11-04 | Philips North America Llc | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.