Heel Snuggler, Reference # 989805603411 99047
Reported: January 26, 2022 Initiated: November 29, 2021 #Z-0507-2022
Product Description
Heel Snuggler, Reference # 989805603411 99047
Reason for Recall
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 2,509,100 units (Updated to 2,515,200 as of 2/15/22)
- Distribution
- US Nationwide and Canada.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Heel Snuggler, Reference # 989805603411 99047. Recalled by Philips North America Llc. Units affected: 2,509,100 units (Updated to 2,515,200 as of 2/15/22).
Why was this product recalled? ▼
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0507-2022.
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