Hillrom WatchCare Incontinence System Recalled for Radio Frequency Interference
Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System for Progressa Bed due to potential radio frequency emissions that may interfere with other medical devices including telemetry monitors and infusion pumps.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which under the rubric guidelines must never score below 4. The hazard involves potential radio frequency interference with critical life-sustaining medical devices including infusion pumps and insulin pumps.
Plain-English summary
The Hillrom Hospital Bed Accessory Watch Care Incontinence Management System for Progressa Bed (Product Code P00697903, UDI/DI 00887761998889) is being recalled by Baxter Healthcare Corporation. A total of 1,137 units are affected by this recall.
The device may emit radio frequency that could potentially interfere with the operation of other medical equipment in the hospital environment. Devices that could be affected include telemetry devices, bladder scanners, fetal monitors/dopplers, infusion pumps, and insulin pumps.
This recall affects healthcare facilities in the United States that use this incontinence management system with Progressa Beds. Healthcare providers should immediately remove affected units from service and contact Baxter Healthcare Corporation for further instructions regarding replacement or corrective measures.
The recalled product
- Product
- Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,137
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00887761998889
- all serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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