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PUBLIC SAFETY RECORD 55063 OF 3,210,000Masimo Corporation
Masimo Corporation
PART_ID LOT_ID 3311 11CE2 3311 E11EA7 3311 11EMM 3311 E11EDJ 3311 11FAU 3311 11FAV 3311 11CE2 3311 11FAW 3311 11GBY 3311 11HGF 3311 11HE6 33
Identify the exact product and model, inspect its condition and check the official safety notice before continued use.
Medical devicesCardiovascularEnglish · United StatesRecall date 2014-11-13
English: Product names, model codes, official notices and manufacturer text remain in the language of the authoritative source. EgoFile interface content is translated.
DATA PROVENANCE
What this page contains
- Record type
- Official safety notice
- Responsible source
- FDA
- Verification
- Data from an official public register
- Source evidence
- Identifier: 130772:Z-0213-2015
- Last source check
- 2 August 2026
- Indexing policy
- Page is eligible for indexing
Important limitation
This record is not a user manual or confirmation of conformity for a specific variant.
Public data with attribution retained100%profile completeness
PRODUCT WORKSPACE
One product. Everything in one place.
Official FDA record. Confirm the complete rating-label code before saving a serial number or following variant-specific instructions.
✓Exact brand and model✓Product category✓Market and language✓Named source✓Official identifier
Keep warranty, history and safety alerts together.
Use cited guidance or create a private EgoFile case.
Quick start
Before first use
- Match the model, date code and identifying label to the official record.
- Read the official recall notice and manufacturer instructions before assembly or use.
- Keep proof of purchase, serial details and recall contact information available.
Daily use
Operate the product correctly
- Use the product only for its intended purpose and within stated age, load and environmental limits.
- Stop when a guard, fastener, restraint, cable or structural part is missing or damaged.
- Keep children and bystanders away from hazards described in the official notice.
Safety
Important precautions
- Stop using a recalled product until the official remedy has been completed.
- Do not improvise repairs, disable guards or substitute safety-critical parts.
- Report fire, shock, injury, collapse or unexpected movement to the manufacturer and appropriate authority.
Maintenance
Maintain reliable operation
- Inspect accessible fasteners, guards, cords, batteries and structural joints regularly.
- Use only approved replacement parts and cleaning methods.
- Recheck recall status after ownership transfer, repair or identification of a different model variant.
OFFICIAL SAFETY ACTION
Oximeter · Employee error
Confirm the complete model, date code and product label before following the corrective measure.
Hazard: Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low S
Official measure: An "Urgent: Advisory Notice," dated 09/30/2014, was sent to customers. The letter informed customers of the problem identified and the actions to be taken. Customers were instructed to evaluate their inventory of Oximetr
Open official safety record ↗COMMON ISSUES AND SYMPTOMS
What the product may be indicating
These are general diagnostic paths for this product category. Error-code numbers differ between brands, markets and revisions, so EgoFile shows a code only after it is confirmed in the exact official manual.
Source policySafe checks are maintained by EgoFile and linked to the official source record. No third-party manual text is copied.
01RECALL
Product matches a safety notice
High priorityWhat it means: The model, date code or product description may be subject to an official corrective action.
First safe check: Stop use and compare the complete identifying label with the official notice.
Stop condition: Follow only the official refund, repair, replacement or disposal remedy.
02DAMAGE
Visible damage or deformation
High priorityWhat it means: Cracks, loose joints, exposed wiring or distorted parts can defeat the intended safety design.
First safe check: Isolate the product and photograph the damage without dismantling it.
Stop condition: Do not reuse until the manufacturer confirms a safe remedy.
03PARTS
Part, guard or fastener is missing
Medium priorityWhat it means: The product may be incomplete, incorrectly assembled or affected by a component failure.
First safe check: Stop use and compare the assembly with the official parts and safety information.
Stop condition: Use only manufacturer-approved replacement parts and procedures.
04LABEL
Model or date code cannot be confirmed
Medium priorityWhat it means: A similar-looking product may not be covered by the same instructions or recall.
First safe check: Locate every rating label, serial number and date code before taking action.
Stop condition: Contact the manufacturer or CPSC when identification remains uncertain.
05INCIDENT
Fire, shock, injury or unexpected movement
High priorityWhat it means: A serious incident or near miss may indicate an immediate product hazard.
First safe check: Move people away, isolate energy only if safe and preserve the product for assessment.
Stop condition: Seek emergency help when needed and report the incident to the manufacturer and authority.
QUICK CHECKS
Three additional checks
Use these checks when no error code is displayed.
Product may match a recall
Compare the complete label and follow the official remedy.
Part is loose or damaged
Stop use and contact the manufacturer before repair or replacement.
Model cannot be confirmed
Do not rely on this summary; verify the label with the official source.
PUBLIC SAFETY CHECK
Check recalls separately from the manual.
No exact model match was attached automatically. Search the official safety records by brand, shorter model number or UPC.
Search safety notices →This page summarizes an official safety record and corrective measure. Confirm the full model, date code and label before taking action.
Open official safety record →