Philips Model 712010 Medical Device Recalled for Potential Immediate Failure
Philips North America is recalling 563 units of Model 712010 medical devices due to a potential for the device to fail immediately after an exposure, causing the system to remain stationary.
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: The recall is classified as FDA Class II, and the source describes a potential for the device to fail immediately after an exposure, causing the system to remain stationary. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Philips North America is recalling 563 units of Model 712010 medical devices. The recall is due to a potential for the device to fail immediately after an exposure, which could cause the system to remain stationary.
The affected devices were distributed nationwide in the United States and internationally to numerous countries, including Australia, Canada, Germany, and the United Kingdom. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should stop using the affected devices and contact Philips North America for further instructions on the recall.
The recalled product
- Product
- Model Number: 712010.
- Manufacturer
- Philips North America
- Category
- Medical Device — Medical Device
- Hazard
- Affected units
- 563
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)
- Model Number: 712010. UDI: (01)00884838115521(21)26000155
- (01)00884838115521(21)26000154
- (01)00884838115521(21)26000151
- (01)00884838115521(21)26000150
- (01)00884838115521(21)26000149
- (01)00884838115521(21)26000148
- (01)00884838115521(21)26000147
- (01)00884838115521(21)26000146
- (01)00884838115521(21)26000145
- (01)00884838115521(21)26000144
- (01)00884838115521(21)26000143
- (01)00884838115521(21)26000142
- (01)00884838115521(21)26000141
- (01)00884838115521(21)26000140
- (01)00884838115521(21)26000139
- (01)00884838115521(21)26000138
- (01)00884838115521(21)26000137
- (01)00884838115521(21)26000136
- (01)00884838115521(21)26000135
- (01)00884838115521(21)26000134
Distribution
Distributed nationwide across the United States.
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