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The Vest®System
HILL-ROM SERVICES PTE. LTD. · Model 500320005 · UDI-DI 00887761998155
10
510(k) clearances
282
Adverse events (6 deaths)
3
Recalls
35
Facilities
Description
Respiratory Care
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-31 | Smiths Medical ASD Inc. | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. |
| 2017-09-15 | HILL-ROM MANUFACTURING, INC. | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subje |
| 2014-11-13 | Aptalis Pharmatech Inc. | Customer notification that the device may be difficult to open or close. |
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