International Medical Devices Database

Manufacturer Address
Childrens Medical Ventures, 191 Wyngate Dr, Monroeville PA 15146-3045
Source
USFDA
2 Events
- Recall of Device Recall GelE Donut, Squishon 2
- Recall of Philips

2 devices in the database

Device Recall GelE Donut, Squishon 2

Model / Serial
All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
Product Classification
General Hospital and Personal Use Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) including the country of Canada.
Product Description
Gel-E Donut, Squishon 2 gel pillows || Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

Philips

Model / Serial
989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971, 989805604631 / 1030271, 989805605051 / 1038140, 989805605061 / 1038141, 989805608801 / U1014557, 989805608811 / U1014559, 989805608831 / U1028969, 989805608841 / U1028970, 989805608851 / U1038140, 989805604231 / 1023384
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including the states of MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV and VA., and the countries of Australia, Belgium and Canada.
Product Description
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.

One manufacturer with a similar name

Learn more about the data here

Childrens Medical Ventures

Manufacturer Parent Company (2017)
Philips
Source
NZMMDSA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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