Drager PT 4000 Phototherapy System Recalled for Incorrect Fuse Rating
Draeger Medical Systems is recalling 65 Drager PT 4000 Phototherapy Systems because they contain a 16 Amp fuse instead of the specified 1.6 Amp fuse, posing a risk of overheating.
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 involves a risk-of-harm product (potential severe overheating/fire) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Draeger Medical Systems, Inc. is recalling 65 units of the Drager PT 4000 Phototherapy System. A routine internal quality check determined that the devices are fitted with a 16 Amp rated fuse rather than the specified 1.6 Amp rated fuse. The affected units were distributed nationwide in the United States and Puerto Rico.
The incorrect fuse rating may prevent the internal fuse from tripping promptly during an internal short-circuit. This could cause the wall outlet circuit breaker to trip first, or the device may severely overheat. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities should stop using the affected Drager PT 4000 Phototherapy Systems immediately. Affected units are identified by catalog number 2M21700 and specific serial number ranges, including ASCF-0037 to ASCF-0061, ASCJ-0037 to ASCJ-0152, ASCL-0001 to ASCL-0025, ASCM-0001 to ASCM-0025, and ASDA-002, 0005, 0006, 0007, 0008, 0009, 0012, 0019, and 0025.
The recalled product
- Product
- Drager PT 4000 Phototherapy System
- Manufacturer
- Draeger Medical Systems, Inc.
- Hazard
- Affected units
- 65
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 (13)
- Catalog number 2M21700 and serial numbers ASCF-0037 TO ASCF-0061
- ASCJ-0037 TO ASCJ-0152
- ASCL-0001 TO ASCL-0025
- ASCM-0001 TO ASCM-0025
- and ASDA-002
- 0005
- 0006
- 0007
- 0008
- 0009
- 0012
- 0019
- 0025.
Distribution
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