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Snuggle Pediatric Array
Inkspace Imaging, Inc. · Model SBA24SH30B · UDI-DI 00860008041302
1
510(k) clearances
136
Adverse events
38
Recalls
76
Facilities
Description
The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) MRI scanners. It consists of 24 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. It includes two identical pads, which each contain 12 elements. The two pads can be positioned separately, such that setup time is minimized. The space dinosaur theme is child friendly and designed to help reduce anxiety during the MR scan.
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.