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Pediatric Body Array

Inkspace Imaging, Inc. · Model PBA24GE30A · UDI-DI 00860008041326

MOS

510(k) clearances

136

Adverse events

Recalls

Facilities

Description

The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy.

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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Data 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.