Allon 2001 Medical Device Heating System Malfunction Risk
Belmont Instrument's Allon 2001 device may heat water above safe limits if sensor connections fail and temperature alarms are disabled. The patient wrap may exceed its set temperature without user notification.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a medical device with a malfunction that could cause patient harm (excessive heat) without user notification. No reported illnesses or injuries are mentioned in the source text, but the hazard is a real malfunction condition (not merely theoretical) that could result in burn injury if sensors disconnect and alarms are disabled.
Plain-English summary
Belmont Instrument LLC is recalling the Allon 2001 (Part Number 200-00263), a medical device that heats water for patient wraps. An investigation found that the device can malfunction in two specific scenarios: (1) if the Human Sensor Board is disconnected from the Controller Board and temperature alarms are disabled, or (2) if the Water In, Water Out, and Thermostat sensors are disconnected from the Human Sensor Board and temperature alarms are disabled.
When either of these conditions occurs, the device will continue heating water above the safe hardware fault limit without alerting the user to the problem. This creates a potential safety hazard where the patient wrap (ThermoWrap) may exceed its set temperature.
Approximately 229 units were distributed worldwide, including in the US states of California, District of Columbia, Louisiana, Massachusetts, New Mexico, Pennsylvania, Texas, Virginia, and Washington, as well as internationally in Belgium, Bolivia, Brazil, Canada, Colombia, Israel, Italy, Portugal, Romania, Sweden, Taiwan, Thailand, and the United Kingdom. Users of affected Allon 2001 devices should review the specific serial numbers listed and contact Belmont Instrument LLC for further guidance.
The recalled product
- Product
- Allon 2001. Part Number: 200-00263
- Manufacturer
- Belmont Instrument LLC
- Affected units
- 229
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 (20)
- Part Number: 200-00263. UDI-DI: 007290107581103
- Serial Numbers: 99111143000002
- 99111143000014
- 99111627300034
- 9993901600001
- 9993901600002
- 9993901600004
- 9993901600006
- 9993901600007
- 9993901600009
- 9995356300005
- 9995356300006
- 9995356300007
- 9995356300008
- 9996673800002
- 99111143000001
- 99111143000003
- 99111143000004
- 99111143000007
- 99111143000008
Distribution
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